Difference between revisions of "User:Shawndouglas/sandbox/sublevel9"

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==Sandbox begins below==
==Sandbox begins below==


As of March 25, 2019
==2. Sample Management==
{|
| STYLE="vertical-align:top;"|
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! 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-2-1]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white;" |'''2.1''' The system shall record and maintain the chain of custody for the laboratory's standards and reagents.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-2]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white;" |'''2.2''' The system shall record the current and historical storage location for the laboratory's standards and reagents.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-3]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white;" |'''2.3''' The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-4]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white;" |'''2.4''' The system shall require the recording of a standard and reagent's first opening date.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-5]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white;" |'''2.5''' The system shall allow only active standards and reagents to be shown as available for use.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-6]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white;" |'''2.6''' The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-7]
  | style="background-color:white;" |'''2.7''' The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, test method, assigned user, and status.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-8]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2]<br />[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.2]
  | style="background-color:white;" |'''2.8''' The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
[https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.2.1]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-9]
  | style="background-color:white;" |'''2.9''' The system should provide a means to manually or automatically track sample inventory amounts and status.
|-
  | style="padding:5px; width:500px;" |[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 5.9.1.1]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-10]
  | style="background-color:white;" |'''2.10''' The system shall be able to link test methods and specifications to standards and reagents.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
[https://www.law.cornell.edu/cfr/text/21/211.166 21 CFR Part 211.166–7]<br />
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/212.40 21 CFR Part 212.40 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/212.61 21 CFR Part 212.61]<br />
[https://www.law.cornell.edu/cfr/text/21/212.70 21 CFR Part 212.70 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58]<br />
[https://www.law.cornell.edu/cfr/text/21/226.58 21 CFR Part 226.58]<br />
[https://www.law.cornell.edu/cfr/text/21/606.65 21 CFR Part 606.65 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/606.151 21 CFR Part 606.151]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-11]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.1.2.1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.2]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.3.2]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.5]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.5]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.7]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.22–25]
  | style="background-color:white;" |'''2.11''' The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.
|-
|}
|}


'''Alaska''':
==3. Core Laboratory Testing and Experiments==
 
{|
The state boasts 75 Limited and 97 Standard Marijuana Cultivation Facilities. The state differentiates a "limited" facility as one with 500 square feet or less of grow operation space, whereas "standard" facilities have no such limitation.<ref name="SummersCult16">{{cite web |url=http://www.alaskajournal.com/2016-03-21/cultivation-licenses-dominate-marijuana-applications |title=Cultivation licenses dominate marijuana applications |author=Summers, D.J. |work=Alaska Journal of Commerce |date=21 March 2016 |accessdate=25 April 2019}}</ref> To review the entire list of 172 cultivation facilities, go to [https://www.commerce.alaska.gov/web/amco/ https://www.commerce.alaska.gov/web/amco/] and look for the link "Licenses and Applications by Status."
| STYLE="vertical-align:top;"|
 
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
Licensing fees for limited are $1,000, and $5,000 for standard.<ref name="AMCOMariLic">{{cite web |url=https://www.commerce.alaska.gov/web/amco/MarijuanaLicenseApplication.aspx |author=Alcohol and Marijuana Control Office |publisher=Alaska Department of Commerce, Community, and Economic Development |accessdate=25 April 2019}}</ref>
|-
 
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
 
|-
'''Arizona''':
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
 
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
The government ties cultivation to dispensaries. However, Arizona state law prohibits making public a list of dispensaries, so the state's cultivators/dispensaries are not publicly known.<ref name="AZDHSFAQsDisp">{{cite web |url=https://www.azdhs.gov/licensing/medical-marijuana/index.php#faqs-dispensary |work=FAQs - Dispensary |title=DI31: Can I get a list of the dispensaries? |author=Arizona Department of Health Services |publisher=Government of Arizona |accessdate=25 April 2019}}</ref>
|-
 
  | style="padding:5px; width:500px;" |
 
[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84 (d)]<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 5.1.3.1]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-1]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.7]
'''Arkansas''':
  | style="background-color:white;" |'''3.1''' The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.
The five cultivation facilities for Arkansas are<ref name="FieldBuild19">{{cite web |url=https://www.arkansasonline.com/news/2019/jan/21/building-underway-all-cannabis-cultivation-sites/ |title=Building underway at all medical marijuana cultivation sites in Arkansas |author=Field, H. |work=Arkansas Democrat Gazette |date=21 January 2019 |accessdate=25 April 2019}}</ref>:
|-
 
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84 (e)]<br />[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-2]
* Bold Team, LLC (Cotton Plant)
  | style="background-color:white;" |'''3.2''' The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.
* Delta Medical Cannabis Co. (Newport)
|-
* Natural State Medicinals Cultivation, LLC (White Hall)
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-3]
* Natural State Wellness Enterprises, LLC (Newport)
  | style="background-color:white;" |'''3.3''' The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.
* Osage Creek Cultivation, LLC (Berryville)
|-
 
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-4]
As of March 15, 2019, three of the five were up and running: Bold Team, Osage Creek Cultivation, and Natural State Medicinals Cultivation.<ref name="BrantleyThird19">{{cite web |url=https://www.arktimes.com/ArkansasBlog/archives/2019/03/15/third-marijuana-cultivation-facility-now-operating |title=Third marijuana cultivation facility now operating |author=Brantley, M. |work=Arkansas Times |date=15 March 2019 |accessdate=25 April 2019}}</ref>
  | style="background-color:white;" |'''3.4''' The system shall be able to check physical, control, and specification limits for an instrument sample.
 
|-
The five facilities were licensed after paying a $100,000 license fee and a $500,000 performance bond.<ref name="GrabensteinArk18">{{cite web |url=https://www.usnews.com/news/best-states/arkansas/articles/2018-07-10/ark-medical-marijuana-panel-issues-5-cultivation-licenses |title=Arkansas Issues 5 Medical Marijuana Cultivation Licenses |author=Grabenstein, H. |work=U.S. News |date=10 July 2018 |accessdate=25 April 2019}}</ref>
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-6]
 
  | style="background-color:white;" |'''3.5''' The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.
 
|-
'''California''':
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-7]
The state of California has more than 550 unique temporary cannabis cultivators, more than 140 unique adult-use cultivators, and more than 160 unique medicinal-use cultivators. As of January 1, 2019, the state no longer has the authority to issue temporary licenses, though normal adult-use and medicinal-use cultivation licenses can still be applied for.<ref name="CalCanNotice19">{{cite web |url=https://cannabis.ca.gov/2019/01/08/notice-regarding-temporary-cannabis-cultivation-license-applications/ |title=Notice Regarding Temporary Cannabis Cultivation License Applications |author=CalCannabis Cultivation Licensing |work=California Cannabis Portal |publisher=Government of California |date=07 January 2019 |accessdate=25 April 2019}}</ref> To review the entire list of more than 850 unique cultivation businesses (note: some companies have more than one license), go to [https://aca6.accela.com/CALCANNABIS/Cap/CapHome.aspx?module=Licenses https://aca6.accela.com/CALCANNABIS/Cap/CapHome.aspx?module=Licenses], select the license type, then select "Active" from the License Status. (Active licenses won't be older than January 1, 2018.)
  | style="background-color:white;" |'''3.6''' The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.
 
|-  
Application and license fees vary depending on facility type. Consult [https://cannabis.ca.gov/faqs/ the FAQ's]] "How much do application/license fees cost?" for the latest regulatory text indicating these fees.
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-8]
 
  | style="background-color:white;" |'''3.7''' The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.
'''Colorado''':
|-  
 
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-9]
 
  | style="background-color:white;" |'''3.8''' The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.
 
|-
'''Connecticut''':
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-10]
 
  | style="background-color:white;" |'''3.9''' The system shall support, at a minimum, the floating point/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.
 
|-
 
  | style="padding:5px; width:500px;" |[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.8.2]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-11]
 
  | style="background-color:white;" |'''3.10''' The system shall allow users to enter operators such as <, >, +, and - with numeric test results.
'''Delaware''':
|-
 
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-12]
 
  | style="background-color:white;" |'''3.11''' The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.
 
|-
 
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-13]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]
'''District of Columbia''':
  | style="background-color:white;" |'''3.12''' The system should effectively alert users upon entry of out-of-specification test results.
 
|-
 
  | style="padding:5px; width:500px;" |
 
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
 
[https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (g)]<br />
'''Florida''':
[https://www.law.cornell.edu/cfr/text/21/606.160 21 CFR Part 606.160]<br />
 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-14]<br />
 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.1.2.3–4]<br />
 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2]<br />
'''Hawaii''':
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.4]<br />
 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.1–4]<br />
 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.16]<br />
 
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.4.2]<br />
 
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.3]<br />
'''Illinois''':
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.8]
 
  | style="background-color:white;" |'''3.13''' The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.
 
|-
 
|}
 
|}
'''Louisiana''':
 
* Due to an absence of independent testing labs, the Louisiana Department of Agriculture is testing, as of October 2018<ref name="KarlinLouisiana18">{{cite web |url=https://www.theadvocate.com/baton_rouge/news/business/article_b05f7ca4-d6fe-11e8-b997-8ff7036b6c47.html |title=Louisiana medical marijuana delayed after state forced to do product testing, company says |author=Karlin, S. |work=The Advocate |date=23 October 2018 |accessdate=27 November 2018}}</ref>
 
 
'''Maine''':
 
 
 
 
'''Maryland''':
 
 
 
'''Massachusetts''':
 
 
 
 
'''Michigan''':
 
 
 
 
'''Minnesota''':
 
 
 
 
'''Missouri''':
 
* Medical marijuana passed in November 2018; Missouri Department of Health and Senior Services needs to develop testing rules<ref name="MarsoMedical18">{{cite web |url=https://www.kansascity.com/living/health-fitness/article221302705.html |title=Medical marijuana in Missouri: When—and if—you can get it |author=Marso, A. |work=The Kansas City Star |date=16 November 2018 |accessdate=27 November 2018}}</ref>
 
 
'''Montana''':
 
 
 
 
'''Nevada''':
 
 
 
 
'''New Hampshire''':
 
 
 
 
'''New Jersey''':
 
 
 
 
'''New Mexico''':
 
 
 
 
'''New York''':
 
 
 
 
'''North Carolina''':
 
 
 
'''North Dakota''':
 
 
 
 
'''Ohio''':
 
 
 
 
'''Oklahoma''':
 
* As of March 11, 2019, a bill containing testing standards and licensing is set to be signed by the governor.<ref name="DishmanUnity19">{{cite web |url=https://newsok.com/article/5625478/unity-bill-for-medical-marijuana-regulations-expected-to-clear-senate-this-week? |title=Unity Bill for medical marijuana regulations expected to clear Senate this week |author=Dishman, D. |work=NewsOK.com |date=11 March 2019 |accessdate=12 March 2019}}</ref>
 
 
 
'''Oregon'''
 
 
 
 
'''Pennsylvania''':
 
 
 
'''Rhode Island''':
 
 
 
 
'''Utah''':
 
* Medical marijuana passed in November 2018; the state is still working on laboratory testing terms<ref name="USLUtahMedical18">{{cite web |url=https://le.utah.gov/interim/2018/pdf/00004612.pdf |format=PDF |title=Utah Medical Cannabis Act Overview |author=Utah State Legislature |publisher=State of Utah |date=14 November 2018 |accessdate=29 November 2018}}</ref>
 
 
'''Vermont''':
 
 
 
 
'''Washington''':
 
 
 
 
'''West Virginia''':
 
* Still working on developing its medical cannabis program.<ref name="BPHOffice">{{cite web |url=https://dhhr.wv.gov/bph/Pages/Medical-Cannabis-Program.aspx |title=Office of Medical Cannabis |work=Bureau for Public Health |publisher=State of West Virginia |accessdate=29 November 2018}}</ref> Draft legislation says the Bureau for Public Health will be responsible for approving testing laboratories.<ref name="BPHTitle64_17">{{cite web |url=http://dhhr.wv.gov/bph/Documents/MedicalCannabis/Proposed%20Rules/Medical%20Cannabis%20Program%20-%20Laboratories%20-%2064%20CSR%20111%20v1.pdf |format=PDF |title=Title 64, Legislative Rule, Bureau for Public Health, Series 111, Medical Cannabis Program - Laboratories |author=Bureau for Public Health |publisher=State of West Virginia |date=14 December 2017 |accessdate=29 November 2018}}</ref>
 
==References==
{{Reflist|colwidth=30em}}

Revision as of 21:23, 19 September 2019

Sandbox begins below

2. Sample Management

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 C-2-1
EPA ERLN Laboratory Requirements 4.11.14
2.1 The system shall record and maintain the chain of custody for the laboratory's standards and reagents.
ASTM E1578-18 C-2-2
EPA ERLN Laboratory Requirements 4.11.14
2.2 The system shall record the current and historical storage location for the laboratory's standards and reagents.
ASTM E1578-18 C-2-3
EPA ERLN Laboratory Requirements 4.11.14
2.3 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.
ASTM E1578-18 C-2-4
EPA ERLN Laboratory Requirements 4.11.14
2.4 The system shall require the recording of a standard and reagent's first opening date.
ASTM E1578-18 C-2-5
EPA ERLN Laboratory Requirements 4.11.14
2.5 The system shall allow only active standards and reagents to be shown as available for use.
ASTM E1578-18 C-2-6
EPA ERLN Laboratory Requirements 4.11.14
2.6 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.
ASTM E1578-18 C-2-7 2.7 The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, test method, assigned user, and status.
ASTM E1578-18 C-2-8
EPA ERLN Laboratory Requirements 3.2
ISO/IEC 17025:2017 7.4.2
2.8 The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.

7 CFR Part 331.17
9 CFR Part 121.17
21 CFR Part 211.84
42 CFR Part 73.17
ASTM E1492-11 4.2.1
ASTM E1578-18 C-2-9

2.9 The system should provide a means to manually or automatically track sample inventory amounts and status.
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1
ASTM E1578-18 C-2-10
2.10 The system shall be able to link test methods and specifications to standards and reagents.

21 CFR Part 211.84
21 CFR Part 211.166–7
21 CFR Part 211.194 (e)
21 CFR Part 212.40 (c)
21 CFR Part 212.61
21 CFR Part 212.70 (e)
21 CFR Part 225.58
21 CFR Part 226.58
21 CFR Part 606.65 (c)
21 CFR Part 606.151
ASTM E1578-18 C-2-11
EPA ERLN Laboratory Requirements 3.1.2.1
EPA ERLN Laboratory Requirements 4.3.2
EPA ERLN Laboratory Requirements 4.11.3.2
EPA QA/G-5 2.2.5
USDA Administrative Procedures for the PDP 8.5
WHO Technical Report Series, #986, Annex 2, 17.7
WHO Technical Report Series, #986, Annex 2, 17.22–25

2.11 The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.

3. Core Laboratory Testing and Experiments

Regulation, Specification, or Guidance Requirement

21 CFR Part 211.84 (d)
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1
ASTM E1578-18 C-3-1
ISO 15189:2012 5.3.2.7

3.1 The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.
21 CFR Part 211.84 (e)
42 CFR Part 493.1252 (d)
ASTM E1578-18 C-3-2
3.2 The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.
42 CFR Part 493.1252 (d)
ASTM E1578-18 C-3-3
3.3 The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.
ASTM E1578-18 C-3-4 3.4 The system shall be able to check physical, control, and specification limits for an instrument sample.
ASTM E1578-18 C-3-6 3.5 The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.
ASTM E1578-18 C-3-7 3.6 The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.
ASTM E1578-18 C-3-8 3.7 The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.
ASTM E1578-18 C-3-9 3.8 The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.
ASTM E1578-18 C-3-10 3.9 The system shall support, at a minimum, the floating point/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.
AIHA-LAP Policies 2018 2A.7.8.2
ASTM E1578-18 C-3-11
3.10 The system shall allow users to enter operators such as <, >, +, and - with numeric test results.
ASTM E1578-18 C-3-12 3.11 The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.
42 CFR Part 493.1241
ASTM E1578-18 C-3-13
EPA ERLN Laboratory Requirements 4.9.11
3.12 The system should effectively alert users upon entry of out-of-specification test results.

21 CFR Part 211.194
21 CFR Part 212.60 (g)
21 CFR Part 606.160
ASTM E1578-18 C-3-14
EPA ERLN Laboratory Requirements 3.1.2.3–4
EPA ERLN Laboratory Requirements 3.2
EPA ERLN Laboratory Requirements 4.3.4
EPA ERLN Laboratory Requirements 4.8.1–4
EPA ERLN Laboratory Requirements 4.11.16
USDA Data and Instrumentation for PDP 5.4.2
USDA Data and Instrumentation for PDP 8.1.3
WHO Technical Report Series, #986, Annex 2, 15.8

3.13 The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.