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We conclude our examination of 20 broad industry categories and the laboratories associated with them, looking at the final five. For each you'll find a brief description with common services and how the lab type affects the average person. As discussed previously, using our client type + function model we dig into examples found in the private, government, and academic sectors and then outline function through activities, sciences, test types, equipment, and unique attributes. A discussion follows in the section after.
<div class="nonumtoc">__TOC__</div>
{{ombox
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| text      = This is sublevel2 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p>
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<div align="center">-----Return to [[User:Shawndouglas/sandbox/sublevel4|the beginning]] of this guide-----</div>
==Sandbox begins below==
__TOC__


==Labs by industry: Part 4==
==6. Reporting==
===Nanotechnology===
{|
[[File:Two microgrippers.jpg|left|400px]]
| STYLE="vertical-align:top;"|
{{clear}}
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
Nanoscience is the study of objects (materials, structures, devices) and phenomena on the nanometer scale. Physicist Richard Feynman's talk titled "There's Plenty of Room at the Bottom" at the end of 1959 helped spark an exploration today of the world of the fantastically small<ref name="NanoGovWhatIs">{{cite web |url=https://www.nano.gov/nanotech-101/what/definition |title=What is Nanotechnology? |work=Nano.gov |publisher=United States National Nanotechnology Initiative |accessdate=13 June 2017}}</ref>, one that has spawned a great number of discoveries and inventions based on nanoscience.<ref name="NanoGovNanoTime">{{cite web |url=https://www.nano.gov/timeline |title=Nanotechnology Timeline |work=Nano.gov |publisher=United States National Nanotechnology Initiative |accessdate=13 June 2017}}</ref> From quantum computing to cellulose nanomaterials, private, public, and academic labs of all types are improving the way we construct, work, and play. These labs provide many different services, including (but not limited to)<ref name="GoddardHandbook12">{{cite book |url=https://books.google.com/books?id=dJ-jIv1Hv2EC&printsec=frontcover |title=Handbook of Nanoscience, Engineering, and Technology |editor=Goddard, W.A.; Brenner, D.W.; Lyshevski, S.E.; Iafrate, G.J. |publisher=CRC Press |edition=3rd |pages=1093 |year=2012 |isbn=9781439860151}}</ref> :
|-
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-6-1]
  | style="background-color:white;" |The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.
|-
  | style="padding:5px; width:500px;" |[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.4]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.4]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.12–15]
  | style="background-color:white;" |The system shall be able to export data in a computer-readable (importable into a relational database) format—such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file—as well as PDF format, for reporting purposes.
|-
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (g) and (h)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-6-2]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.4]<br />[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.2]
  | style="background-color:white;" |The system shall alert users in advance to cases when the sample may be out-of-specification or may not meet expected turnaround time requirements.
|-
  | style="padding:5px; width:500px;" |[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. G-2]
  | style="background-color:white;" |The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., "less than X mg/L") when doing so would provide relevant information to the report recipient.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/40/141.33 40 CFR Part 141.33]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (c–e)]<br />
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.2.1]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.10.2–5]<br />
[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.8.1]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-12 and -32]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-6-3]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 8]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 4.5.2]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.8.3]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.5.1]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.2.1]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.3.1]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.43]
  | style="background-color:white;" |The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-6-4]
  | style="background-color:white;" |The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-6-5]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.8.1]
  | style="background-color:white;" |The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/7/331.5 7 CFR Part 331.5]<br />
[https://www.law.cornell.edu/cfr/text/9/121.5 9 CFR Part 121.5–6]<br />
[https://www.law.cornell.edu/cfr/text/21/58.185 21 CFR Part 58.185]<br />
[https://www.law.cornell.edu/cfr/text/21/312.64 21 CFR Part 312.64]<br />
[https://www.law.cornell.edu/cfr/text/21/812.150 21 CFR Part 812.150]<br />
[https://www.law.cornell.edu/cfr/text/21/812.200 21 CFR Part 812.200]<br />
[https://www.law.cornell.edu/cfr/text/40/141.31 40 CFR Part 141.31]<br />
[https://www.law.cornell.edu/cfr/text/40/141.721 40 CFR Part 141.721]<br />
[https://www.law.cornell.edu/cfr/text/40/part-370/subpart-C 40 CFR Part 370 Subpart C]<br />
[https://www.law.cornell.edu/cfr/text/40/part-372/subpart-B 40 CFR Part 372 Subpart B]<br />
[https://www.law.cornell.edu/cfr/text/40/part-704 40 CFR Part 704]<br />
[https://www.law.cornell.edu/cfr/text/40/part-717/subpart-A 40 CFR Part 717 Subpart A]<br />
[https://www.law.cornell.edu/cfr/text/40/720.40 40 CFR Part 720.40]<br />
[https://www.law.cornell.edu/cfr/text/42/73.5 42 CFR Part 73.5–6]<br />
[https://www.law.cornell.edu/cfr/text/42/493.43 42 CFR Part 493.43 (d)]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-7]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-6-7]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.3.1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.12–15]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.3.2]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 9.1]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP (throughout)]
  | style="background-color:white;" |The system should, in addition to standard reports, provide the means for custom reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator/sponsor reports.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/58.185 21 CFR Part 58 Sec. 58.185 (c)]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.10.9–10]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.8]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 9.1]
  | style="background-color:white;" |The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.
|-
|}
|}


* characterization and testing of nanoscale devices and materials
==7. Document Management==
* improvement of the performance of existing technologies and materials
{|
* development of new materials
| STYLE="vertical-align:top;"|
* research and development of nanosafety plans
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
* research and development of nanotech standards
|-
* research and development of nanomanufacturing and -measurement equipment
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
* development of nanomedicines
|-
 
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
''How do nanotechnology laboratories intersect the average person's life on a daily basis?'' As the technology and research around nanotechnology is still in somewhat of an infant phase, it's less clear how these labs affect the average person. The fact that by definition visualizing the design of nanotechnology due to its nano scale is challenging doesn't make relating to nanotech labs any easier either. The idea of the quantum computer, a computational device utilizing nature's small-scale physics, is still in early development, but nanotechnology labs such as MIT's Lincoln Lab continue to research and apply nanoscience to the hardware that could make up the first practical quantum computer.<ref name="HardestyToward16">{{cite web |url=http://news.mit.edu/2016/toward-practical-quantum-computers-0808 |title=Toward practical quantum computers |author=Hardesty, L. |work=MIT News |publisher=Massachusetts Institute of Technology |date=08 August 2016 |accessdate=14 June 2017}}</ref> Moving from the theoretical to the more applicable, the United States National Nanotechnology Initiative list several applications of nanotechnology found in products today, including solar panel films, windmill blades, gas lift valves, and airplane cabin filters.<ref name="NanoGovBenefits">{{cite web |url=https://www.nano.gov/you/nanotechnology-benefits |title=Benefits and Applications |work=Nano.gov |publisher=United States National Nanotechnology Initiative |accessdate=14 June 2017}}</ref>
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
 
|-
====Client types====
  | style="padding:5px; width:500px;" |
 
[https://www.law.cornell.edu/cfr/text/7/331 7 CFR Part 331 (throughout)]<br />
'''Private''' - Private nanotech labs are usually associated with a major company or part of a private-public partnership, as the equipment to analyze and manufacture at the nano scale can be costly.
[https://www.law.cornell.edu/cfr/text/9/121 9 CFR Part 121 (throughout)]<br />
 
[https://www.law.cornell.edu/cfr/text/21/7 21 CFR Part 7 (throughout)]<br />
Examples include:
[https://www.law.cornell.edu/cfr/text/21/58 21 CFR Part 58 (throughout)]<br />
 
[https://www.law.cornell.edu/cfr/text/21/211 21 CFR Part 211 (throughout)]<br />
* [http://www.hpl.hp.com/research/qip/ Hewlett-Packard Laboratories' Quantum Information Processing Group]
[https://www.law.cornell.edu/cfr/text/21/212 21 CFR Part 212 (throughout)]<br />
* [https://www-03.ibm.com/press/us/en/pressrelease/52508.wss IBM Research's NanoLab]
[https://www.law.cornell.edu/cfr/text/21/225 21 CFR Part 225 (throughout)]<br />
* [http://english.nanoctr.cas.cn/au/bi/ National Center for Nanoscience and Technology]
[https://www.law.cornell.edu/cfr/text/21/226 21 CFR Part 226 (throughout)]<br />
 
[https://www.law.cornell.edu/cfr/text/21/312 21 CFR Part 312 (throughout)]<br />
'''Government''' - Government-based nanotechnology labs are typically themed towards a certain sub-branch, from nanomedicine (cancer research) to military (war machines).
[https://www.law.cornell.edu/cfr/text/21/606 21 CFR Part 606 (throughout)]<br />
 
[https://www.law.cornell.edu/cfr/text/21/810 21 CFR Part 810 (throughout)]<br />
Examples include:
[https://www.law.cornell.edu/cfr/text/21/812 21 CFR Part 812 (throughout)]<br />
 
[https://www.law.cornell.edu/cfr/text/21/820 21 CFR Part 820 (throughout)]<br />
* [http://www.nrc-cnrc.gc.ca/eng/solutions/collaborative/nint_index.html Canada National Institute for Nanotechnology]
[https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (throughout)]<br />
* [https://ncl.cancer.gov/ U.S. National Cancer Institute's Nanotechnology Characterization Laboratory]
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (throughout)]<br />
* [https://www.nrl.navy.mil/nanoscience/about U.S. Naval Research Laboratory's Nanoscience Research Laboratory]
[https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (throughout)]<br />
 
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (throughout)]<br />
'''Academic''' - The nanotech labs of higher education tend to have a focus on post-graduate education and research, occasionally subcontracting its expertise out to the private domain.
[https://www.law.cornell.edu/cfr/text/42/73 42 CFR Part 73 (throughout)]<br />
 
[https://www.law.cornell.edu/cfr/text/42/493.1200 42 CFR Part 493.1200]<br />
Examples include:
[https://www.law.cornell.edu/cfr/text/42/493.1232 42 CFR Part 493.1232]<br />
 
[https://www.law.cornell.edu/cfr/text/42/493.1239 42 CFR Part 493.1239]<br />
* [http://cni.columbia.edu/shared-labs/ Columbia University's Columbia Nano Initiative Shared Labs Facilities]
[https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251]<br />
* [http://snl.mit.edu/ Massachusetts Institute of Technology's Space Nanotechnology Laboratory]
[https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (j)]<br />
* [https://mntl.illinois.edu/ University of Illinois' Micro+Nanotechnology Lab]
[https://www.law.cornell.edu/cfr/text/45/part-164 45 CFR Part 164 (throughout)]<br />
 
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories (throughout)]<br />
====Functions====
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL (throughout)]<br />
 
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual (throughout)]<br />
''What are the most common functions?'' analytical, research/design, QA/QC, and teaching
[https://www.astm.org/Standards/E1188.htm ASTM E1188-11 3.5.2]<br />
 
[https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.3.3.3 and 4.4.4]<br />
''What materials, technologies, and/or aspects are being analyzed, researched, and quality controlled?'' nanoemulsions, nanomaterials, nanomedicines
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 D-1-1]<br />
 
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy (throughout)]<br />
''What sciences are being applied in these labs?'' astrophysics, biology, biomedical engineering, chemistry, electrical engineering, microfabrication, molecular biology, molecular engineering, organic chemistry, physics, statistics
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 (throughout)]<br />
 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements (throughout)]<br />
''What are some examples of test types and equipment?''
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 (throughout)]<br />
 
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC (throughout)]<br />
'''Common test types include''':  
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point (throughout)]<br />
 
[https://www.iso.org/standard/56115.html ISO 15189:2012 4.3]<br />
Acute toxicity, Biocompatibility, Characterization, Chronic toxicity, Design review and evaluation, Ecotoxicology, Electrophoresis, Efficacy, Friction, Grain and particle size, Irritation, Nanoparticulate, Proficiency, Safety, Spectral, Subchronic toxicity, Surface topography
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.5.3]<br />
 
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.3]<br />
'''Industry-related lab equipment may include''':  
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 5.3]<br />
 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 5.5]<br />
atom probe, atomic force microscope, atomic force microscopy-Raman system, atomic layer deposition system, calorimeter, cryogenic probe station, dynamic light scattering equipment, electron backscattered diffraction system, ellipsometer, flow chemistry reactor, helium ion beam microscope, micro hardness tester, micropositioning system, nanoparticle characterization system, optical tweezers, particle size analyzer, plasma etching system, safety cabinet, scanning electron microscope, scanning near-field optical microscope, separation membrane, spectrometer, spectrophotometer, transmission electron microscope, viscometer, X-ray camera, X-ray diffractometer
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.3.2]<br />
 
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8]<br />
''What else, if anything, is unique about the labs in the nanotech industry?'' The laboratory equipment of a nanotechnology lab stands out among other industry labs, in so much that it tends to be specialized and expensive, regardless of what sub-field of nanotechnology is being studied.<ref name="BoysenNano08">{{cite web |url=http://www.nanotech-now.com/columns/?article=182 |title=For Rent: One Nano Research Lab… |author=Boysen, E. |work=Nanotechnology Now |publisher=7th Wave, Inc |date=24 March 2008 |accessdate=14 June 2017}}</ref><ref name="DamaseOpen15">{{cite journal |title=Open source and DIY hardware for DNA nanotechnology labs |journal=Journal of Biological Methods |author=Damase, T.R.; Stephens, D.; Spencer, A.; Allen, P.B. |volume=2 |issue=3 |pages=e24 |year=2015 |doi=10.14440/jbm.2015.72 |pmid=26457320 |pmc=PMC4598940}}</ref> This extends to the laboratory space itself, where conditions must be specifically maintained for optimal results; this includes electromagnetic shielding, reduced acoustic levels, reduced vibrations, and carefully maintained temperatures.<ref name="USNRLAbout">{{cite web |url=https://www.nrl.navy.mil/nanoscience/about |title=About the NSI |work=U.S. Naval Research Laboratory |publisher=Department of the Navy |accessdate=14 June 2017}}</ref>
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP (throughout)]<br />
 
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP (throughout)]<br />
====LIMSwiki resources====
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP (throughout)]<br />
 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2 (throughout)]
* None
  | style="background-color:white;" |The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.
 
|-  
====Further reading====
  | style="padding:5px; width:500px;" |
 
[https://www.law.cornell.edu/cfr/text/7/331 7 CFR Part 331 (throughout)]<br />
* {{cite book |url=https://books.google.com/books?id=SGtYBQAAQBAJ&printsec=frontcover |title=A Laboratory Course in Nanoscience and Nanotechnology |author=Poinern, G.E.J. |publisher=CRC Press |year=2014 |pages=260 |isbn=9781482231038}}
[https://www.law.cornell.edu/cfr/text/9/121 9 CFR Part 121 (throughout)]<br />
 
[https://www.law.cornell.edu/cfr/text/21/7 21 CFR Part 7 (throughout)]<br />
 
[https://www.law.cornell.edu/cfr/text/21/58 21 CFR Part 58 (throughout)]<br />
<div align="center"><hr width="50%"></div>
[https://www.law.cornell.edu/cfr/text/21/211 21 CFR Part 211 (throughout)]<br />
 
[https://www.law.cornell.edu/cfr/text/21/212 21 CFR Part 212 (throughout)]<br />
===Petrochemical===
[https://www.law.cornell.edu/cfr/text/21/225 21 CFR Part 225 (throughout)]<br />
[[File:TASNEE 001.jpg|left|400px]]
[https://www.law.cornell.edu/cfr/text/21/226 21 CFR Part 226 (throughout)]<br />
{{clear}}
[https://www.law.cornell.edu/cfr/text/21/312 21 CFR Part 312 (throughout)]<br />
A petrochemical laboratory is focused on analyzing the properties and constituents of various petrochemicals (and their feedstock, including petroleum, natural gas, and coal) for the purposes of ensuring their safety, quality, development, and improvement. Secondarily, these labs may provide a platform for R&D and teaching. Petrochemical labs are found in the private and academic sectors, and occasionally in government, providing many different services, including (but not limited to)<ref name="ChaudhuriFund16">{{cite book |url=https://books.google.com/books?id=mKQnDet5IUoC&printsec=frontcover |title=Fundamentals of Petroleum and Petrochemical Engineering |author=Chaudhuri, U.R. |publisher=CRC Press |year=2016 |pages=411 |isbn=9781439851616}}</ref>:  
[https://www.law.cornell.edu/cfr/text/21/606 21 CFR Part 606 (throughout)]<br />
 
[https://www.law.cornell.edu/cfr/text/21/810 21 CFR Part 810 (throughout)]<br />
* analysis for purity
[https://www.law.cornell.edu/cfr/text/21/812 21 CFR Part 812 (throughout)]<br />
* analysis for contaminates
[https://www.law.cornell.edu/cfr/text/21/820 21 CFR Part 820 (throughout)]<br />
* corrosion testing
[https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (c)]<br />
* characterization testing
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (throughout)]<br />
* environmental testing
[https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (e)]<br />
* quality control testing
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (throughout)]<br />
 
[https://www.law.cornell.edu/cfr/text/42/73 42 CFR Part 73 (throughout)]<br />
''How do petrochemical laboratories intersect the average person's life on a daily basis?'' The U.S. Energy Information Administration (EIA) estimated that of the approximately 7.19 billion barrels of petroleum consumed in the U.S. in 2016, 48 percent of it went towards motor gasoline, 20 percent of it went to distillate fuel, and eight percent was used as jet fuel.<ref name="EIAWhatAre17">{{cite web |url=https://www.eia.gov/tools/faqs/faq.php?id=41&t=6 |title=What are petroleum products, and what is petroleum used for? |work=Frequently Asked Questions |publisher=U.S. Energy Information Administration |date=10 March 2017 |accessdate=14 June 2017}}</ref> The EIA also notes that while petroleum is used as a feedstock for the creation of plastic in the U.S., it's not the main feestock for plastic, and regardless, the EIA is unable to determine what percentage of petroleum consumed in the U.S. went towards the creation of plastics<ref name="EIAHowMuch17">{{cite web |url=https://www.eia.gov/tools/faqs/faq.php?id=34&t=6 |title=How much oil is used to make plastic? |work=Frequently Asked Questions |publisher=U.S. Energy Information Administration |date=17 May 2017 |accessdate=14 June 2017}}</ref> (though simple math using the numbers previously provided proves that it must be 24 percent or less). Even so, these facts alone can't but cement the idea that the world as we know it today would not be as it is without petroleum and petrochemical laboratories and their laboratorians. One could argue that laboratories developing renewable source of energy and the equipment to harness it are more important from an environmental standpoint, but the point still stands: we currently depend heavily on petrochemicals as energy and to create thousands of products.<ref name="SpeightTheChem14">{{cite book |url=https://books.google.com/books?id=ZDPOBQAAQBAJ&pg=PA773 |title=The Chemistry and Technology of Petroleum |chapter=Chapter 27: Petrochemicals |author=Speight, J.G. |publisher=CRC Press |year=2014 |pages=773–795 |isbn=9781439873908}}</ref>
[https://www.law.cornell.edu/cfr/text/42/493.1200 42 CFR Part 493.1200]<br />
 
[https://www.law.cornell.edu/cfr/text/42/493.1232 42 CFR Part 493.1232]<br />
====Client types====
[https://www.law.cornell.edu/cfr/text/42/493.1239 42 CFR Part 493.1239]<br />
 
[https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251]<br />
'''Private''' - These labs provide an array of analytical services as third-party testers and consultants, or they work as company-based or independent research and development laboratories developing new petrochemical-based products.
[https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (j)]<br />
 
[https://www.law.cornell.edu/cfr/text/42/493.1773 42 CFR Part 493.1773 (c–d)]<br />
Examples include:
[https://www.law.cornell.edu/cfr/text/45/part-160.310 45 CFR Part 160.310]<br />
 
[https://www.law.cornell.edu/cfr/text/45/part-164 45 CFR Part 164 (throughout)]<br />
* [http://www.huffmanlabs.com/?page_id=160 Huffman Hazen Laboratories]
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories (throughout)]<br />
* [http://www.sgs.com/en/oil-gas/downstream/refining-processing-and-supply/laboratory-services/petrochemical-testing SGS]
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL (throughout)]<br />
* [https://www.sumitomo-chem.co.jp/english/rd/laboratories/petrochemicals.html Sumitomo Chemical]
[https://www.astm.org/Standards/E1188.htm ASTM E1188-11 3.5.2]<br />
 
[https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.3.3.3 and 4.4.4]<br />
 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 D-1-2]<br />
'''Government''' - At least in the United States, government petrochemical labs are typically working to ensure consistent fuel quality, product safety, and fuel transportation methods. Secondarily they may act as environmental response centers, reacting to petroleum spills and natural spills or developing improved remediation methods.
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy (throughout)]<br />
 
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 (throughout)]<br />
Examples include:
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements (throughout)]<br />
 
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 (throughout)]<br />
* [https://www.wildlife.ca.gov/OSPR/Science/Petroleum-Chemistry-Lab California Petroleum Chemistry Lab]
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC (throughout)]<br />
* [https://www.colorado.gov/pacific/ops/PetroleumLaboratory Colorado Petroleum Laboratory]
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point (throughout)]<br />
* [http://agr.georgia.gov/state-fuel-oil-lab.aspx Georgia State Fuel Oil Laboratory]
[https://www.iso.org/standard/56115.html ISO 15189:2012 (throughout)]<br />
 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 (throughout)]<br />
 
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8]<br />
'''Academic''' - Academic petrochemical labs are providing education to undergraduate and graduate students, as well as driving new research into petrochemical extraction and infrastructure.
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP (throughout)]<br />
 
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP (throughout)]<br />
Examples include:
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP (throughout)]<br />
 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2 (throughout)]
* [http://www.delmar.edu/Chemical_Lab_Tech/chemical_lab_tech.aspx Del Mar College's Environmental/Petrochemical Lab Technology Program]
  | style="background-color:white;" |The system shall have the ability to readily provide access to electronic documents such as standard operating procedures, quality manuals, instrument manuals, information exchange agreements, and other applicable documents to designated personnel and officials.
* [https://engineering.tamu.edu/petroleum/research Texas A&M University's Harold Vance Department of Petroleum Engineering]
|-  
* [https://cpe.drupal.ku.edu/research%20labs University of Kansas' Tertiary Oil Recovery Program]
  | style="padding:5px; width:500px;" |
 
[https://www.law.cornell.edu/cfr/text/21/820.40 21 CFR Part 820.40 (a)]<br />
====Functions====
[https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251 (e)]<br />
 
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.3]<br />
''What are the most common functions?'' analytical, research/design, QA/QC, and teaching
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 D-1-3]<br />
 
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 11]<br />
''What materials, technologies, and/or aspects are being analyzed, researched, and quality controlled?'' aromatics, coal, feedstocks, intermediate chemicals, monomers, natural gas, petroleum, polymers, sediment, solvents, sulfur, trace metals, water, wear metals
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.2]<br />
 
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.9]<br />
''What sciences are being applied in these labs?'' chemistry, environmental science, geology, geophysics, mathematics, petroleum engineering, physics, thermodynamics
[https://www.iso.org/standard/56115.html ISO 15189:2012 4.3]<br />
 
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.5.3]<br />
''What are some examples of test types and equipment?''
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.3]<br />
 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.5.2]<br />
'''Common test types include''':
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.3.2]<br />
 
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.5]<br />
Acid and base number, Aniline point, API gravity, Basic sediment and water, Biodegradation, Boiling - freezing - melting point, Calorimetry, Carbon-hydrogen ratio, Cargo inspection and sampling, Cetane, Chemical and materials compatibility, Cloud point, Combustion, Compliance/Conformance, Conductivity, Congealing point, Conradson Carbon Residue, Contamination, Corrosion, Damage tolerance, Decomposition, Density, Dissolved gas, Doctor test, Emissions, Evaporation loss, Flash point, Fluid dynamics, Geochemistry, Geophysics, Heating value, Hydraulic, Hydrocarbon group type, Immersion, Impurity, Kauri-butanol value, Leak, Lightning, Lubricity, Macroetch, Mobility, Moisture, Molecular weight, Octane, Oxidation reduction potential, Oxidation stability, Passivation, Permeability, Peroxide value, pH, Plating and coating evaluations, Pour point, Pressure, Process safety, Proficiency, Quality control, Radioactivity, Radiochemical, Ramsbottom Carbon Residue, Refractive index, Salt content, Saponification value, Seismic, Smoke point, Stress corrosion cracking, Surface tension, Thermal, Vapor pressure, Velocity and flow, Viscosity, Weathering
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.5]
 
  | style="background-color:white;" |The system shall be able to clearly provide the most current version of a document and archive prior versions.
'''Industry-related lab equipment may include''':  
|-
 
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 D-1-4]
amperostat, balance, chromatographic, combustion analyzer, constant temperature bath, density meter, dissolved oxygen meter, evaporation loss analyzer, flashpoint tester, flocculator, fume hood, hot plate, hygrometer, iodine flask, metallic iron analyzer, muffle furnace, oil-in-water analyzer, oxidation stability analyzer, pH meter, pycnometer, refractometer, rheometer, shakers and stirrers, specific gravity flask, spectrometer, spectrophotometer, thermometer, thin film oven, titrator, turbidity meter, vapor pressure analyzer, viscometer, water bath
  | style="background-color:white;" |The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.
 
|-
''What else, if anything, is unique about the labs in the petrochemical industry?'' Because of the environmental consequences of petrochemical and feedstock pollution of the environment, petrochemical labs share some of the same characteristics of environmental labs. Also like environmental labs, petrochemical labs have their fair share of field analyses, both on land and on the water.
  | style="padding:5px; width:500px;" |
 
[https://www.law.cornell.edu/cfr/text/21/211.21 21 CFR Part 211.21 (c)]<br />
====LIMSwiki resources====
[https://www.law.cornell.edu/cfr/text/21/212.20 21 CFR Part 212.20 (c)]<br />
 
[https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (c)]<br />
* None
[https://www.law.cornell.edu/cfr/text/21/226.58 21 CFR Part 226.58 (e)]<br />
 
[https://www.law.cornell.edu/cfr/text/21/820.250 21 CFR Part 820.250 (b)]<br />
====Further reading====
[https://www.law.cornell.edu/cfr/text/42/493.43 42 CFR Part 493.43 (c)]<br />
 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 D-1-5]<br />
* {{cite book |url=https://books.google.com/books?id=mKQnDet5IUoC&printsec=frontcover |title=Fundamentals of Petroleum and Petrochemical Engineering |author=Chaundhuri, U.R. |publisher=CRC Press |year=2016 |pages=411 |isbn=9781439851616}}
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 5]<br />
 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.5]<br />
 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.1.3]<br />
<div align="center"><hr width="50%"></div>
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.4]<br />
 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.14]
===Pharmaceutical===
  | style="background-color:white;" |The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.
[[File:Generic Propecia.jpg|left|400px]]
|-  
{{clear}}
  | style="padding:5px; width:500px;" |
 
[https://www.law.cornell.edu/cfr/text/21/212.20 21 CFR Part 212.20 (c)]<br />
The pharmaceutical laboratory is complex, but at its core the laboratorians in them aim to better develop, analyze, improve, and quality control the drugs and medical devices that improve humans' and animals' quality of life. Due to the potential health risks of ingesting/implanting a poorly tested pharmaceutical/medical device, these labs tend to be heavily regulated by governments. In fact, the governments themselves will often have their own labs to test for product quality and lab compliance. Universities provide not only education programs for students and graduate research opportunities but also pharmaceutical analysis and outreach programs. Pharmaceutical labs are found in the private, government, and academic sectors, providing many different services, including (but not limited to)<ref name="WuAssay10">{{cite book |url=https://books.google.com/books?id=qxKqC1aGLBIC&pg=PA347 |title=Assay Development: Fundamentals and Practices |chapter=13.6 HTS Operation Management |author=Wu, G. |publisher=John Wiley & Sons |year=2010 |pages=347–354 |isbn=9780470583111}}</ref><ref name="AvomeenPharmLab">{{cite web |url=https://www.avomeen.com/industries/pharma/ |title=cGMP Pharmaceutical Development Laboratory |publisher=Avomeen Analytical Services |accessdate=15 June 2017}}</ref><ref name="HansenIntro12">{{cite book |url=https://books.google.com/books?id=S7S6a4OYTasC&printsec=frontcover |title=Introduction to Pharmaceutical Chemical Analysis |author=Hansen, S.; Pedersen-Bjergaard, S.; Rasmussen, K. |publisher=John Wiley & Sons |year=2012 |pages=624 |isbn=9781119954330}}</ref>:
[https://www.law.cornell.edu/cfr/text/21/212.70 21 CFR Part 212.70 (b)]<br />
 
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.2.4]<br />
* hit picking/screening of potential therapeutics
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. G-12, -14, and -15]<br />
* method development and validation
[http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4]<br />
* stability and photostability testing
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.4]<br />
* shelf life testing
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.2.1]<br />
* bioequivalence testing
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.4]<br />
* dissolution testing
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 4.11]<br />
* impurities testing
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.13]
* counterfeit testing
  | style="background-color:white;" |The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.
* formulation optimization
|-
* quality control
  | style="padding:5px; width:500px;" |
 
[https://www.law.cornell.edu/cfr/text/7/331.10 7 CFR Part 331.10]<br />
''How do pharmaceutical laboratories intersect the average person's life on a daily basis?'' In a 2000 journal article published in ''Journal of Automated Methods & Management in Chemistry'', author Juanita M. Hawkins of Jansen Pharmaceutica noted the following: "Understanding the contributions that the laboratory can make in product/process development, process improvement, market surveillance and general business is key to the pharmaceutical business today. Poor laboratory practice yields compliance issues, increased cost, increased cycle time and delayed product introductions."<ref name="HawkinsTheImport00">{{cite journal |title=The Importance of the Laboratory to the Pharmaceutical Business |journal=Journal of Automated Methods & management in Chemistry |author=Hawkins, J.M. |volume=22 |issue=2 |pages=47–52 |year=2000 |doi=10.1155/S1463924600000067 |pmid=18924858 |pmc=PMC2548258}}</ref> While a very business-centered statement, reading between the lines — and further into the journal article — reveals why properly run pharmaceutical labs are important to the average person: "customers expect the product to be safe and efficacious" and "that it meets all specifications."<ref name="HawkinsTheImport00" /> All but those participating in a primitive society will at one point (if not frequently) have the need to be treated with a pharmaceutical drug or device. Without the associated laboratories and quality control procedures in place, the pharmaceuticals would be of poor quality (if they existed at all) and endanger many lives. Even if you take something as simple as an aspirin, remember that a lab developed it, improved it, and/or quality controlled it for your benefit.
[https://www.law.cornell.edu/cfr/text/7/331.15 7 CFR Part 331.15]<br />
 
[https://www.law.cornell.edu/cfr/text/9/121.10 9 CFR Part 121.10 ]<br />
====Client types====
[https://www.law.cornell.edu/cfr/text/9/121.15 9 CFR Part 121.15 ]<br />
 
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (i)]<br />
'''Private''' - These labs are either part of a pharmaceutical company's portfolio or are third-party contract labs that provide extensive analysis and consulting services.
[https://www.law.cornell.edu/cfr/text/21/58.29 21 CFR Part 58.29]<br />
 
[https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25]<br />
Examples include:
[https://www.law.cornell.edu/cfr/text/21/225.10 21 CFR Part 225.10]<br />
 
[https://www.law.cornell.edu/cfr/text/21/226.10 21 CFR Part 226.10]<br />
* [https://www.avomeen.com/industries/pharma/ Avomeen Analytical Services]
[https://www.law.cornell.edu/cfr/text/21/226.40 21 CFR Part 226.40]<br />
* [http://www.medipharmlab.com/services/pharmaceutical-analysis.php Medipharm Laboratories]
[https://www.law.cornell.edu/cfr/text/21/820.25 21 CFR Part 820.25]<br />
* [https://www.pacelabs.com/life-sciences/pharmaceuticals.html Pace Analytical Services]
[https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (c)]<br />
 
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (g-2)]<br />
'''Government''' - Government pharmaceutical labs typically act as either research centers or in an official regulatory capacity to ensure product quality and lab compliance.
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (h-2)]<br />
 
[https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (h)]<br />
Examples include:
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br />
 
[https://www.law.cornell.edu/cfr/text/42/73.10 42 CFR Part 73.10]<br />
* [https://frederick.cancer.gov/Science/Bdp/Default.aspx Frederick National Laboratory for Cancer Research's Biopharmaceutical Development Program]
[https://www.law.cornell.edu/cfr/text/42/73.15 42 CFR Part 73.15]<br />
* [http://www.govtlab.gov.hk/english/abt_aasd_pcs.htm Hong Kong's Pharmaceutical Chemistry Section of the Analytical & Advisory Services Division]
[https://www.law.cornell.edu/cfr/text/42/493.43 42 CFR Part 493.43 (c)]<br />
* [https://www.fda.gov/ScienceResearch/FieldScience/ucm258937.htm U.S. Food and Drug Administration's Detroit District Laboratory]
[https://www.law.cornell.edu/cfr/text/42/493.1235 42 CFR Part 493.1235]<br />
 
[https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251]<br />
'''Academic''' - The pharmaceutical engineering labs in the academic sector provide not only education programs for students and graduate research opportunities but also pharmaceutical analysis and outreach programs.
[https://www.law.cornell.edu/cfr/text/45/164.308 45 CFR Part 164.308]<br />
 
[https://www.law.cornell.edu/cfr/text/45/164.530 45 CFR Part 164.530]<br />
Examples include:
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6]<br />
 
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.2]<br />
* [https://pharmlabs.unc.edu/ University of North Carolina - Chapel Hill's Pharmaceutics and Compounding Laboratory]
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.2.2]<br />
* [http://padproject.nd.edu/get-involved/distributed-pharmaceutical-analysis-lab/ University of Notre Dame's Distributed Pharmaceutical Analysis Lab]
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Appendix 1]<br />
* [http://egr.uri.edu/biolab/ University of Rhode Island's Pharmaceutical Engineering Laboratory]
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br />
 
[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 (various parts)]<br />
====Functions====
[http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12]<br />
 
[http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1–3]<br />
''What are the most common functions?'' analytical, research/design, QA/QC, and teaching
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-5]<br />
 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 D-1-6]<br />
''What materials, technologies, and/or aspects are being analyzed, researched, and quality controlled?'' biological agents and samples, contaminates, drug substances, elemental metals, microbials, proteins, raw materials, solvents
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-6]<br />
 
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-2]<br />
''What sciences are being applied in these labs?'' biochemistry, biology, chemistry, genetics, molecular biology, neuroscience, pathology, pharmacology, physiology, posology, toxicology
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 7.4]<br />
 
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 10 and 17]<br />
''What are some examples of test types and equipment?''
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 1]<br />
 
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<br />
'''Common test types include''':
[https://www.iso.org/standard/56115.html ISO 15189:2012 4.1.2.1]<br />
 
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.1.6]<br />
Absorption, Active ingredient, Acute contact, Acute oral, Acute toxicity, Alcohol level, Allergy, Altitude, Amino acid analysis, Angle of repose, Antimicrobial, Bioavailability, Bioburden, Biocompatibility, Bioequivalence, Biosafety, Boiling - freezing - melting point, C- and N-terminal, Carcinogenicity, Characterization, Chronic toxicity, Circular dichroism, Cleanliness, Clinical diagnostic, Colorimetric, Compendial, Compliance/Conformance, Composition, Congealing point, Contamination, Cytotoxicity, De novo protein, Detection, Developmental and reproductive toxicology, Disintegration, Dissolution, Disulfide bridge, Efficacy, Electrophoresis, Endotoxin, Expiration dating, Extractables and leachables, Flavor, Formulation, Fragrance, Friability, Functional observational battery, Genotoxicity, Human factors, Identification, Impurity, Ingredient, Ingress, Inhalation, Irritation, Iterative, Locomotor activity, Lot release, Microfluidics, Minimum bactericidal concentration, Minimum inhibitory concentration, Moisture, Molecular weight, Mutagenicity, Nanoparticulate, Organic carbon, Osmolality, Osmolarity, Oxidation reduction potential, Oxidation stability, Pathogen, Peptide mapping, Permeability, pH, Pharmacokinetic, Photostability, Phototoxicity, Polarimetry, Post-translational modification, Preservative challenge, Process safety, Proficiency, Protein analysis, Protein characterization, Purity, Pyrogenicity, Quality control, Radioactivity, Radiochemical, Safety, Saponification value, Sensitization, Solubility, Specific rotation, Stability, Sterility, Subchronic toxicity, Surface tension, Thermal, Total viable count, Toxicokinetic, Ultraviolet, Usability, Validation, Verification, Virucidal efficacy, Water activity
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.1.9]<br />
 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.2]<br />
'''Industry-related lab equipment may include''':  
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.3]<br />
 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.5]<br />
animal monitoring equipment, balance, biological safety cabinet, blood and hematology analyzers, calorimeter, cell counter, cell disruptor, cell harvesting system, centrifuge, chemical synthesizer, chromatographic, cryocooler, dissolution equipment, dissolved oxygen meter, DNA shearing sonicator, drying and heating chamber, electrophoresis equipment, flow cytometer, flow injection analyzer, freeze dryer, freezer, fume hood, glove box, hit-picking system, incubator, inhalation chamber, interferometer, laminar flow cabinet, liquid handling equipment, metallic iron analyzer, microplate equipment, particle counter, PCR equipment, pH meter, powder analyzer, pumps and sprayers, refractometer, rheometer, solid phase extraction equipment, spectrometer, spectrophotometer, steam sterilizer, sonicator, turbidity meter, UV chamber, vacuum evaporator, viscometer, water purification system
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.6]<br />
 
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 1.1.2]<br />
''What else, if anything, is unique about the labs in the pharmaceutical industry?'' Quality control is important to any laboratory; however, in the pharmaceutical industry, many countries like the U.S. place extra emphasis on pharmaceutical quality control labs. "The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control ... This includes pharmaceutical laboratories used for in-process and finished product testing," says the U.S. Food and Drug Administration.<ref name="USFDAPharmGuide14">{{cite web |url=https://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074918.htm |title=Guide to Inspections of Pharmaceutical Quality Control Laboratories |publisher=U.S. Food and Drug Administration |date=25 November 2014 |accessdate=14 June 2017}}</ref> Even the World Health Organization puts focus on their importance, pointing out<ref name="WHOGoodPract10">{{cite web |url=http://apps.who.int/medicinedocs/en/d/Js18681en/ |title=WHO Good Practices for Pharmaceutical Quality Control Laboratories |publisher=World Health Organization |date=2010 |pages=49 |accessdate=14 June 2017}}</ref>:
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]<br />
 
  | style="background-color:white;" |The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.
<blockquote>The government, normally through the national medicines regulatory authority (NMRA), may establish and maintain a pharmaceutical quality control laboratory to carry out the required tests and assays to verify that APIs, excipients and pharmaceutical products meet the prescribed specifications. Large countries may require several pharmaceutical quality control laboratories which conform to national legislation, and appropriate arrangements should, therefore, be in place to monitor their compliance with a quality management system.</blockquote>
|-
 
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 D-1-7]
As Maura May notes for ''Pharmaceutical Manufacturing'', the importance of these labs not only lies in protecting the public and company; they're a product of a competitive environment, where spending, cleanliness, and lead times are vital.<ref name="MayLeaning14">{{cite web |url=http://www.pharmamanufacturing.com/articles/2014/leaning-the-quality-control-laboratory/ |title=Leaning the Quality Control Laboratory |author=May, M. |work=Pharmaceutical Manufacturing |publisher=Putman Media |date=16 September 2014 |accessdate=17 June 2017}}</ref>
  | style="background-color:white;" |The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.
 
|-
====LIMSwiki resources====
  | style="padding:5px; width:500px;" |[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.10.6]
 
  | style="background-color:white;" |The system shall support the addition of accurate cross-references and page numbers to new documents.
* [[Pharmacoinformatics]]
|-
 
  | style="padding:5px; width:500px;" |[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.3.4]
====Further reading====
  | style="background-color:white;" |The system shall be capable of uniquely identifying documents created in and added to the system.
 
|-
* {{cite book |url=https://books.google.com/books?id=PpfT6bSF4kcC&printsec=frontcover |title=The Textbook of Pharmaceutical Medicine |author=Griffin, J.P.; Posner, J.; Barker, G.R. |edition=7th |publisher=John Wiley & Sons |year=2013 |pages=856 |isbn=9781118532355}}
|}
 
|}
 
<div align="center"><hr width="50%"></div>
 
===Power and utility===
[[File:Iwachishi-51-r1.JPG|left|400px]]
{{clear}}
The labs in the power and utility industry cover at least two broad categories: power generation and transmission (electrical engineering and its sub-branches) and water treatment and distribution (water engineering and management, including water purification chemistry). Natural gas transmission and distribution (natural gas engineering) is a third type, though more often than not these labs appear in the upstream and midstream distribution chain (i.e., within the petrochemical industry). In several parts of the world, the development and maintenance of local, regional, and even national broadband internet infrastructure is increasingly also considered a responsibility of the public utility system. These labs are found in the private and academic sectors, and occasionally in government, providing many different services, including (but not limited to)<ref name="BartiromoElect16">{{cite book |url=https://books.google.com/books?id=tt37CwAAQBAJ&printsec=frontcover |title=Electrical Measurements in the Laboratory Practice |author=Bartiromo, R.; De Vincenzi, M. |publisher=Springer |year=2016 |pages=286 |isbn=9783319311029}}</ref><ref name="PizziWater05">{{cite book |url=https://books.google.com/books?id=8nDIGStFlyMC&pg=PA153 |chapter=Chapter 12: Testing and Laboratory Procedures |title=Water Treatment Operator Handbook |author=Pizzi, N.G. |publisher=American Water Works Association |year=2005 |edition=2nd |pages=153–164 |isbn=9781583213711}}</ref>:  
 
* hardware design, verification, and optimization
* real-time digital power system (RTDS) simulation
* magnetic material characterization
* short circuit analysis
* high-voltage analysis
* forensic and incident analysis
* environmental simulation testing
* certification testing
* water quality monitoring and analysis
 
''How do power and utility laboratories intersect the average person's life on a daily basis?'' If you live in a location where access to power and clean water are regular, to the point of being easy to take for granted, then your life is positively affected by a power and utility laboratory. Sometimes things go wrong, though, as they have done in the city of Flint, Michigan, where government leadership failures and cost-cutting measures led to a problematic water treatment plant and water source to continue to be used despite warnings the water was dangerous.<ref name="AugensteinFlint17">{{cite web |url=https://www.laboratoryequipment.com/news/2017/06/flint-water-crisis-five-michigan-officials-charged-involuntary-manslaughter |title=Flint Water Crisis: Five Michigan Officials Charged with Involuntary Manslaughter |author=Augenstein, S. |work=Laboratory Equipment |publisher=Advantage Business Media |date=14 June 2017 |accessdate=15 June 2017}}</ref> The Flint crisis is a reminder that when processes break down in a public utilities lab — whether caused internally or from higher up in government — people get hurt or even die. Power, water, natural gas, and even broadband internet: most enjoy and expect these basic services on a daily basis, and sound laboratory analysis and research ensures this holds true.
 
====Client types====
 
'''Private''' - These company labs provide a wide array of testing services to third-party clients, conduct research, and even provide certification testing.
 
Examples include:
 
* [http://www.powertechlabs.com/testing/high-power/ Powertech Labs]
* [https://www.sandc.com/en/products--services/services/laboratory-services/ S&C Electric Company]
* [https://www.sintef.no/en/all-laboratories/sintef-energy-lab/ SINTEF]
 
'''Government''' - These are federal, state, or local laboratories responsible for testing and maintaining the safety of water supplies, developing and improving electrical infrastructure, or researching new technologies for public utilities. Occasionally local municipalities will post requests for proposal to contract out regulation-mandated water quality testing rather than invest in the infrastructure to do it their self.
 
Examples include:
 
* [http://pompanobeachfl.gov/index.php/pages/utilities/utilities City of Pompano Beach, Florida's Utilities Laboratory]
* [http://ei.pnnl.gov/ Pacific Northwest National Laboratory's Electricity Infrastructure Group]
* [http://www.powerlab.dk/about_powerlabdk PowerLabDK]
 
'''Academic''' - Academic power and utility labs are largely instructional, with graduate level research helping to expand the field.
 
Examples include:
 
* [http://sites.psu.edu/microgridtestbedpsh/ Penn State Harrisburg University's PPL Electric Utilities Lab]
* [http://www.oit.edu/wilsonville/academics/labs/power-lab Oregon Tech Wilsonville's Power Lab]
* [http://www.ucdenver.edu/academics/colleges/Engineering/Programs/Electrical-Engineering/Laboratories/Pages/PowerLab.aspx University of Colorado Denver's Power Laboratory]
 
====Functions====
 
''What are the most common functions?'' analytical, research/design, QA/QC, and teaching
 
''What materials, technologies, and/or aspects are being analyzed, researched, and quality controlled?'' actuators, conductors, electrical converters, energy storage, high-voltage direct-current links, hydroelectric generators, networking equipment, superconductors, transformers, transmission lines, wastewater, water
 
''What sciences are being applied in these labs?'' chemistry, control engineering, electrical engineering, electrochemistry, electromagnetism, electronics, forensic science, nanotechnology, physics, power engineering, signal processing
 
''What are some examples of test types and equipment?''
 
'''Common test types include''':  
 
Accelerated stress testing, Accelerated weathering, Acoustical, Aging, Anion, Antimicrobial, Artificial pollution, Bioburden, Chemical and biochemical oxygen demand, Cleanliness, Climatics, Comparative Tracking Index, Compliance/Conformance, Compression, Corrosion, Current and current switching, Damage tolerance, Decomposition, Degradation, Dielectric withstand, Efficiency, Electromagnetic compatibility, Electromagnetic interference, Electrostatic discharge, Emissions, Endurance, Environmental stress-cracking resistance, Failure, Fatigue, Fault simulation, Flash point, Geothermal, Hydraulic, Immersion, Impact, Incident analysis, Induction motor fault, Internal arc, Lightning, Macroetch, Mechanical, Mechanical durability, Minimum bactericidal concentration, Minimum inhibitory concentration, Out-of-phase making and breaking, Partial discharge, pH, Plating and coating evaluations, Power quality, Pressure, Proficiency, Radioactivity, Radio interference voltage, Reliability, Resistance - capacitance - inductance, Short-circuit withstand, Short-line fault, Solar, Stress corrosion cracking, Temperature-rise, Tensile, Thermal, Torque, Turbidity, Velocity and flow, Voltage, Weathering
 
'''Industry-related lab equipment may include''':  
 
''Electrical engineering'': arbitrary waveform generator, circuit simulator, configurable test grids, current and voltage probes, inverter systems, LCR meter, machine drive and controller systems, magnetometer, microcontroller systems, multimeter, oscilloscope, potentiometer, primary metering unit, real-time digital power system simulator, Rogowski coil, semiconductor curve tracer, spectrum analyzer, tachometer, temperature camera
 
''Water engineering'': adenosine triphosphate meter, biocide test kit, borescope, burette, centrifuge, chlorination test kit, colorimeter, conductivity meter, dissolved oxygen meter, Erlenmeyer flask, hydrometer, incubator, ''Legionella'' test kit, oxidation-reduction potential meter, pH meter, purge and trap equipment, reagents, salinity meter, settling cone, spectrophotometer, thermometer, total dissolved solids meter, turbidity meter
 
''Natural gas engineering'': See Petrochemical section.
 
''What else, if anything, is unique about the labs in the power and utility industry?'' Looking at the lab equipment list above, it's relatively easy to tell that those labs focusing on electrical engineering are by and far dry labs, whereas water engineering labs are (no pun intended) of the more typical wet type. A reliable power supply and clean drinking water are easy to take for granted in first-world countries, but both are backed by laboratorians working in very differently equipped labs.
 
====LIMSwiki resources====
 
* None
 
====Further reading====
 
* {{cite book |url=https://books.google.com/books?id=NlXOBQAAQBAJ&printsec=frontcover |title=Principles of Power Engineering Analysis |editor=Degeneff, R.C.; Hesse, M.H. |publisher=CRC Press |year=2011 |pages=452 |isbn=9781466515345}}
 
* {{cite book |url=https://books.google.com/books?id=dd2juAAACAAJ |title=Standard Methods for the Examination of Water and Wastewater |editor=Rice, E.W.; Baird, R.B.; Eaton, A.D.; Clesceri, C.S. |edition=22nd |publisher=American Public Health Association |year=2012 |pages=1496 |isbn=9780875530130}}
 
 
<div align="center"><hr width="50%"></div>
 
===Veterinary===
[[File:Iranian cat in clinic.jpg|left|400px]]
{{clear}}
Veterinary laboratories are to animals as clinical reference/diagnostic labs are to humans. These labs are designed with many of the same instruments found in a human diagnostic lab, with slight variations, and they conduct both clinical (serving the patient) and public health (serving the population) activities. Veterinary labs are found in the private, government, and academic sectors and provide many different services, including (but not limited to)<ref name="UCDVGLForensics">{{cite web |url=https://www.vgl.ucdavis.edu/forensics/ |title=VGL Forensics |publisher=University of California - Davis |accessdate=21 June 2017}}</ref><ref name="AVDLS">{{cite web |url=http://agi.alabama.gov/divisions/veterinary-diagnostic-labs/diagnostic-laboratories |title=State Diagnostic Laboratories |publisher=Alabama Department of Agriculture & Industries |accessdate=21 June 2017}}</ref><ref name="SiroisLab14">{{cite book |url=https://books.google.com/books?id=LW3XBQAAQBAJ&printsec=frontcover |title=Laboratory Procedures for Veterinary Technicians |author=Sirois, M. |publisher=Elsevier Health Sciences |year=2014 |edition=6th |pages=448 |isbn=9780323243575}}</ref>:  
 
* diagnostic consultation
* toxicology
* DNA profiling and testing
* disease surveillance
* educational outreach
 
''How do veterinary laboratories intersect the average person's life on a daily basis?'' The most obvious way veterinary labs impact our lives is via the animals we care for. From hamster to elephant, a veterinary laboratory is responsible for diagnosing disease in animals, aiding veterinarians in the treatment process. They also work behind the scenes, investigating cases of food-borne illness and disease outbreaks in animal populations, allowing quicker action against at-fault food manufacturers and potent disease vectors. Without these laboratories, feed, rescue, and companion animals of all types would face worse outcomes, and our edible meat sources would more often be contaminated, putting human health at risk as well.
 
====Client types====
 
'''Private''' - These labs provide third-party analysis and consultation services for animal owners and other veterinary labs.
 
Examples include:
 
* [http://www.abaxislabs.com/ Abaxis Veterinary References Laboratories]
* [http://avlstl.com/ Advanced Veterinary Laboratory]
* [http://nationalbiovet.com/ National Bio Vet Laboratory]
 
'''Government''' - As previously mentioned, many universities lump veterinary science programs with agriculture programs. You see some of this carry over to the government-run laboratories conducting animal health and disease diagnostic activities, typically though the government's agriculture department. Despite animal science as a scientific discipline arguably being more closely aligned with agriculture science than veterinary science<ref name="FlandersExploring11">{{cite book |url=https://books.google.com/books?id=WT1Ws2o3keYC&pg=PA38 |title=Exploring Animal Science |author=Flanders, F. |publisher=Cengage Learning |pages=38–39 |year=2011 |isbn=9781435439528}}</ref>, those government animal health labs are typically overseen and operated by veterinarians (see examples).
 
Examples include:
 
* [http://agi.alabama.gov/divisions/veterinary-diagnostic-labs/diagnostic-laboratories Alabama State Veterinary Diagnostic Laboratories]
* [http://agriculture.mo.gov/animals/health/diagnosticlabs.php Missouri State Animal Health Diagnostic Laboratories]
* [http://www.ohioagriculture.gov/addl/ Ohio Animal Disease Diagnostic Laboratory]
 
'''Academic''' - At least in the United States, academic veterinary laboratories typically act as both teaching labs for students and as diagnostic or disease tracking facilities for paying clients and the public. Those providing third-party services will also be accredited by one or more associations such as the American Association of Veterinary Laboratory Diagnosticians.
 
Examples include:
 
* [https://www.vgl.ucdavis.edu/forensics/ University of California - Davis' Veterinary Genetics Laboratory Forensic Unit]
* [http://vetmed.illinois.edu/vet-resources/veterinary-diagnostic-laboratory/ University of Illinois at Urbana-Champaign's Veterinary Diagnostic Laboratory]
* [http://vmdl.missouri.edu/ University of Missouri's Veterinary Medical Diagnostic Laboratory]
 
====Functions====
 
''What are the most common functions?'' analytical, research/design, QA/QC, and teaching
 
''What materials, technologies, and/or aspects are being analyzed, researched, and quality controlled?'' avians, biological specimens, cadavers, canines, DNA, exotic animals, equines, felines
 
''What sciences are being applied in these labs?'' clinical chemistry, clinical microbiology, cytopathology, genetics, hematology, histopathology, immunohematology, immunology, parasitology, pathophysiology, reproductive biology, surgical pathology, toxicology, virology
 
''What are some examples of test types and equipment?''
 
'''Common test types include''':  
 
Acute contact, Acute oral, Acute toxicity, Allergy, Amino acid analysis, Antimicrobial, Bioaccumulation, Bioburden, Blood culture, Blood gases, Blood typing, Biophysical profile, Calorimetry, Characterization, Chronic toxicity, Colorimetric, Complete blood count, Compliance/Conformance, Cytopathology, Detection, Electrolyte and mineral panel, Genetic, Genotype, Hematocrit, Hemoglobin, Immunoassay, Immunofluorescence, Immunohistochemistry, Infectious disease, Kidney function, Lipid profile, Liver function, Metabolic panel, Minimum bactericidal concentration, Minimum inhibitory concentration, Neurotoxicity, Nutritional, Osmolality, Osmolarity, Parasitic, pH, Proficiency, Protein analysis, Protein characterization, Red blood cell count, Sensitization, Specific gravity, Subchronic toxicity, Thyroid function, Urine culture, Wildlife toxicology
 
'''Industry-related lab equipment may include''':  
 
artificial insemination equipment, autoclave, balance, biohazard container, biosafety cabinet, centrifuge, chromatographic, clinical chemistry analyzer, colorimeter, desiccator, dissolved oxygen meter, dry bath, fume hood, homogenizer, hotplate, incubator, magnetic stirrer, microcentrifuge tube, microplate reader, microscope, multi-well plate, orbital shaker, PCR machine, personal protective equipment, pH meter, Petri dish, pipettor, powered air purifying respirators, refractometer, spectrophotometer, syringes, test tube and rack, thermometer, urinalysis device, veterinary table, water bath
 
''What else, if anything, is unique about the labs in the veterinary industry?'' While taking a pet to the veterinarian and having a biological sample analyzed is expected and ordinary, many people tend not to also be aware of the public health role many government and academic veterinary laboratories play. Described as veterinary public health (VPH) by the World Health Organization, the veterinarian makes "contributions to the physical, mental and social well-being of humans through an understanding and application of veterinary science".<ref name="WHO_VPH">{{cite web |url=http://www.who.int/zoonoses/vph/en/ |title=Veterinary public health (VPH) |work=Zoonoses |publisher=World Health Organization |accessdate=21 June 2017}}</ref> Noah and Ostrowski break this concept down into six core domains in the ''Merck Veterinary Manual''<ref name="NoahRole">{{cite web |url=http://www.merckvetmanual.com/public-health/public-health-primer/role-of-the-veterinarian-in-public-health-one-health |title=Role of the Veterinarian in Public Health/One Health |work=Merck Veterinary Manual |author=Noah, D.L.; Ostrowski, S.R. |publisher=Merck & Co., Inc |accessdate=21 June 2017}}</ref>:  
 
* Diagnosis, surveillance, epidemiology, control, prevention, and elimination of zoonotic diseases
* Laboratory animal facility and diagnostic laboratory health aspect management
* Biomedical research
* Health education and outreach
* Production and control of biologic products and medical devices
* Governmental and legislative activity
 
====LIMSwiki resources====
 
* None
 
====Further reading====
 
* {{cite book |url=https://books.google.com/books?id=qTayAAAAQBAJ&printsec=frontcover |title=Veterinary Technician's Handbook of Laboratory Procedures |author=Bellwood, B.; Andrasik-Catton |publisher=John Wiley & Sons |year=2013 |pages=200 |isbn=9781118726044}}
 
 
<div align="center"><hr width="50%"></div>
 
==References==
{{Reflist|colwidth=30em}}
 
<!--Place all category tags here-->

Revision as of 22:59, 13 September 2019

This is sublevel2 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see my discussion page instead.

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6. Reporting

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 C-6-1 The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.
EPA ERLN Laboratory Requirements 3.4
EPA ERLN Laboratory Requirements 4.1.4
EPA ERLN Laboratory Requirements 4.12–15 		The system shall be able to export data in a computer-readable (importable into a relational database) format—such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file—as well as PDF format, for reporting purposes.
42 CFR Part 493.1291 (g) and (h)
ASTM E1578-18 C-6-2
EPA ERLN Laboratory Requirements 4.11.4
EPA QA/G-5 2.4.2 		The system shall alert users in advance to cases when the sample may be out-of-specification or may not meet expected turnaround time requirements.
ABFT Accreditation Manual Sec. G-2 The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., "less than X mg/L") when doing so would provide relevant information to the report recipient.

40 CFR Part 141.33
42 CFR Part 493.1291 (c–e)
AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2
AAVLD Requirements for an AVMDL Sec. 5.4.2.1
AAVLD Requirements for an AVMDL Sec. 5.10.2–5
AIHA-LAP Policies 2018 2A.7.8.1
ABFT Accreditation Manual Sec. E-12 and -32
ASTM E1578-18 C-6-3
EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8
EPA 815-R-05-004 Chap. VI, Sec. 8
ISO 15189:2012 4.5.2
ISO 15189:2012 5.8.3
ISO/IEC 17025:2017 7.5.1
ISO/IEC 17025:2017 7.8.1.1
ISO/IEC 17025:2017 7.8.2.1
ISO/IEC 17025:2017 7.8.3.1
WHO Technical Report Series, #986, Annex 2, 15.43

The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.
ASTM E1578-18 C-6-4 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.
ASTM E1578-18 C-6-5
ISO 15189:2012 5.8.1 		The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.

7 CFR Part 331.5
9 CFR Part 121.5–6
21 CFR Part 58.185
21 CFR Part 312.64
21 CFR Part 812.150
21 CFR Part 812.200
40 CFR Part 141.31
40 CFR Part 141.721
40 CFR Part 370 Subpart C
40 CFR Part 372 Subpart B
40 CFR Part 704
40 CFR Part 717 Subpart A
40 CFR Part 720.40
42 CFR Part 73.5–6
42 CFR Part 493.43 (d)
ABFT Accreditation Manual Sec. E-7
ASTM E1578-18 C-6-7
CJIS Security Policy 5.3.1
EPA ERLN Laboratory Requirements 4.12–15
EPA QA/G-5 2.3.2
OECD GLP Principles 9.1
USDA Administrative Procedures for the PDP (throughout)

The system should, in addition to standard reports, provide the means for custom reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator/sponsor reports.

21 CFR Part 58 Sec. 58.185 (c)
AAVLD Requirements for an AVMDL Sec. 5.10.9–10
ISO/IEC 17025:2017 7.8.8
OECD GLP Principles 9.1

The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.

7. Document Management

Regulation, Specification, or Guidance Requirement

7 CFR Part 331 (throughout)
9 CFR Part 121 (throughout)
21 CFR Part 7 (throughout)
21 CFR Part 58 (throughout)
21 CFR Part 211 (throughout)
21 CFR Part 212 (throughout)
21 CFR Part 225 (throughout)
21 CFR Part 226 (throughout)
21 CFR Part 312 (throughout)
21 CFR Part 606 (throughout)
21 CFR Part 810 (throughout)
21 CFR Part 812 (throughout)
21 CFR Part 820 (throughout)
29 CFR Part 1910.134 (throughout)
29 CFR Part 1910.1030 (throughout)
29 CFR Part 1910.1200 (throughout)
29 CFR Part 1910.1450 (throughout)
42 CFR Part 73 (throughout)
42 CFR Part 493.1200
42 CFR Part 493.1232
42 CFR Part 493.1239
42 CFR Part 493.1251
42 CFR Part 493.1291 (j)
45 CFR Part 164 (throughout)
AAFCO QA/QC Guidelines for Feed Laboratories (throughout)
AAVLD Requirements for an AVMDL (throughout)
ABFT Accreditation Manual (throughout)
ASTM E1188-11 3.5.2
ASTM E1492-11 4.3.3.3 and 4.4.4
ASTM E1578-18 D-1-1
CJIS Security Policy (throughout)
EPA 815-R-05-004 (throughout)
EPA ERLN Laboratory Requirements (throughout)
EPA QA/G-5 (throughout)
E.U. Commission Directive 2003/94/EC (throughout)
FDA Hazard Analysis Critical Control Point (throughout)
ISO 15189:2012 4.3
ISO 15189:2012 5.5.3
ISO 15189:2012 5.9.3
ISO/IEC 17025:2017 5.3
ISO/IEC 17025:2017 5.5
ISO/IEC 17025:2017 8.3.2
OECD GLP Principles 8
USDA Administrative Procedures for the PDP (throughout)
USDA Data and Instrumentation for PDP (throughout)
USDA Sample Processing and Analysis Procedures for PDP (throughout)
WHO Technical Report Series, #986, Annex 2 (throughout)

The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.

7 CFR Part 331 (throughout)
9 CFR Part 121 (throughout)
21 CFR Part 7 (throughout)
21 CFR Part 58 (throughout)
21 CFR Part 211 (throughout)
21 CFR Part 212 (throughout)
21 CFR Part 225 (throughout)
21 CFR Part 226 (throughout)
21 CFR Part 312 (throughout)
21 CFR Part 606 (throughout)
21 CFR Part 810 (throughout)
21 CFR Part 812 (throughout)
21 CFR Part 820 (throughout)
29 CFR Part 1910.134 (c)
29 CFR Part 1910.1030 (throughout)
29 CFR Part 1910.1200 (e)
29 CFR Part 1910.1450 (throughout)
42 CFR Part 73 (throughout)
42 CFR Part 493.1200
42 CFR Part 493.1232
42 CFR Part 493.1239
42 CFR Part 493.1251
42 CFR Part 493.1291 (j)
42 CFR Part 493.1773 (c–d)
45 CFR Part 160.310
45 CFR Part 164 (throughout)
AAFCO QA/QC Guidelines for Feed Laboratories (throughout)
AAVLD Requirements for an AVMDL (throughout)
ASTM E1188-11 3.5.2
ASTM E1492-11 4.3.3.3 and 4.4.4
ASTM E1578-18 D-1-2
CJIS Security Policy (throughout)
EPA 815-R-05-004 (throughout)
EPA ERLN Laboratory Requirements (throughout)
EPA QA/G-5 (throughout)
E.U. Commission Directive 2003/94/EC (throughout)
FDA Hazard Analysis Critical Control Point (throughout)
ISO 15189:2012 (throughout)
ISO/IEC 17025:2017 (throughout)
OECD GLP Principles 8
USDA Administrative Procedures for the PDP (throughout)
USDA Data and Instrumentation for PDP (throughout)
USDA Sample Processing and Analysis Procedures for PDP (throughout)
WHO Technical Report Series, #986, Annex 2 (throughout)

The system shall have the ability to readily provide access to electronic documents such as standard operating procedures, quality manuals, instrument manuals, information exchange agreements, and other applicable documents to designated personnel and officials.

21 CFR Part 820.40 (a)
42 CFR Part 493.1251 (e)
AAVLD Requirements for an AVMDL Sec. 4.3
ASTM E1578-18 D-1-3
EPA 815-R-05-004 Chap. III, Sec. 11
EPA ERLN Laboratory Requirements 4.2.4.2
EPA QA/G-5 2.1.9
ISO 15189:2012 4.3
ISO 15189:2012 5.5.3
ISO 15189:2012 5.9.3
ISO/IEC 17025:2017 7.5.2
ISO/IEC 17025:2017 8.3.2
USDA Administrative Procedures for the PDP 5.5
WHO Technical Report Series, #986, Annex 2, 15.5

The system shall be able to clearly provide the most current version of a document and archive prior versions.
ASTM E1578-18 D-1-4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.

21 CFR Part 211.21 (c)
21 CFR Part 212.20 (c)
21 CFR Part 212.60 (c)
21 CFR Part 226.58 (e)
21 CFR Part 820.250 (b)
42 CFR Part 493.43 (c)
ASTM E1578-18 D-1-5
EPA 815-R-05-004 Chap. IV, Sec. 5
ISO/IEC 17025:2017 6.5
ISO/IEC 17025:2017 7.2.1.3
USDA Administrative Procedures for the PDP 8.4
WHO Technical Report Series, #986, Annex 2, 15.14

The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.

21 CFR Part 212.20 (c)
21 CFR Part 212.70 (b)
AAVLD Requirements for an AVMDL Sec. 5.4.2.4
ABFT Accreditation Manual Sec. G-12, -14, and -15
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4
EPA QA/G-5 2.2.4
ISO/IEC 17025:2017 7.2.2.1
USDA Administrative Procedures for the PDP 8.4
WHO Technical Report Series, #986, Annex 2, 4.11
WHO Technical Report Series, #986, Annex 2, 15.13

The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.

7 CFR Part 331.10
7 CFR Part 331.15
9 CFR Part 121.10
9 CFR Part 121.15
21 CFR Part 11.10 (i)
21 CFR Part 58.29
21 CFR Part 211.25
21 CFR Part 225.10
21 CFR Part 226.10
21 CFR Part 226.40
21 CFR Part 820.25
29 CFR Part 1910.134 (c)
29 CFR Part 1910.1030 (g-2)
29 CFR Part 1910.1030 (h-2)
29 CFR Part 1910.1200 (h)
29 CFR Part 1910.1450 (f)
42 CFR Part 73.10
42 CFR Part 73.15
42 CFR Part 493.43 (c)
42 CFR Part 493.1235
42 CFR Part 493.1251
45 CFR Part 164.308
45 CFR Part 164.530
AAFCO QA/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6
AAVLD Requirements for an AVMDL Sec. 5.2
AAVLD Requirements for an AVMDL Sec. 5.4.2.2
AAVLD Requirements for an AVMDL Appendix 1
ABFT Accreditation Manual Sec. B
AIHA-LAP Policies 2018 (various parts)
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1–3
ASTM E1578-18 C-3-5
ASTM E1578-18 D-1-6
ASTM E1578-18 E-1-6
E.U. Annex 11-2
E.U. Commission Directive 2003/94/EC Article 7.4
EPA 815-R-05-004 Chap. III, Sec. 10 and 17
EPA 815-R-05-004 Chap. IV, Sec. 1
EPA QA/G-5 2.1.8
ISO 15189:2012 4.1.2.1
ISO 15189:2012 5.1.6
ISO 15189:2012 5.1.9
ISO/IEC 17025:2017 6.2.2
ISO/IEC 17025:2017 6.2.3
ISO/IEC 17025:2017 6.2.5
ISO/IEC 17025:2017 6.2.6
OECD GLP Principles 1.1.2
USDA Administrative Procedures for the PDP 6.1

 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.
ASTM E1578-18 D-1-7 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.
AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5
EPA ERLN Laboratory Requirements 4.10.6 		The system shall support the addition of accurate cross-references and page numbers to new documents.
AAVLD Requirements for an AVMDL Sec. 4.3.4 The system shall be capable of uniquely identifying documents created in and added to the system.
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