Difference between revisions of "User:Shawndouglas/sandbox/sublevel10"

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


==Laboratory informatics software acquisition and implementation==
==4. Results Review and Verification==
{|
| 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.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br />
[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-4-1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.5.1.4]
  | style="background-color:white;" |'''4.1''' The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.
|-
  | style="padding:5px; width:500px;" |
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-2]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2]
  | style="background-color:white;" |'''4.2''' The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68]<br />
[https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br />
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (a)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.188 21 CFR Part 211.188]<br />
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
[https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-3]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7]<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 Article 9.2]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9]
  | style="background-color:white;" |'''4.3''' The system shall accurately maintain a full audit trail for modified results.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-28–29]<br />
[[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.7.2 and 7.7.3]<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 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 5.9.4–5]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-4]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.6]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2–3 and 4.9.11]<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 2.2.10]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.1]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 10]
  | style="background-color:white;" |'''4.4''' The system shall provide one or more levels of review, as well as interpretation and documentation of results—whether entered manually or via an automated process—before release.
|-
  | style="padding:5px; width:500px;" |
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-5]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2]
  | style="background-color:white;" |'''4.5''' The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.
|-
  | style="padding:5px; width:500px;" |
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-6]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]
  | style="background-color:white;" |'''4.6''' The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.
|-
|}
|}


===Buy versus rent===
==5. Sample, Experiment, and Study Approval and Verification==
 
{|
===Named versus concurrent===
| STYLE="vertical-align:top;"|
 
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
===Implementation===
|-
 
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
===Hosting===
|-
====Self====
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
====Cloud====
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
 
|-
Does the cloud hosting provider provide purpose-built, reliable and secure cloud hosting infrastructure housed in a state-of-the-art data center that is SSAE 16 SOC 2 certified?
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-5-1]<br />[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.9–10]
 
  | style="background-color:white;" |'''5.1''' The system shall accurately record details of a sample's final disposition.
Are industry standard hardware, software, and configuration practices employed, ensuring first-class performance, security and reliability, with a full 100% uptime guarantee?
|-  
 
  | style="padding:5px; width:500px;" |[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.7.2]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-5-2]
Are global cloud networks employed to provide a seamless global cloud hosting service?
  | style="background-color:white;" |'''5.2''' The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.
 
|-
Can the provide meet special requirements for HIPAA, CLIA, 21 CFR part 11 or other regulatory compliance data?
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-5-3]<br />[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 6.1]
 
  | style="background-color:white;" |'''5.3''' The system should provide appropriate functions for specific sample statuses like "approved" and "rejected," including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.
Features include:
|-
* comprehensive redundancy
|}
* failover
|}
* data backup and protection (database backups and system-wide backups in secondary location for redundancy)
* SSL security and encryption
 
====SaaS====
 
===Maintenance, support, and warranty===
Service plan
 
Maintenance is the business of keeping your system up and running, including all updates/fixes and upgrades within major versions, and in the case of cloud-hosted accounts, all of the IT that goes along with that. Any cloud provider should provide their own dedicated cloud infrastructure at a state-of-the-art SSAE 16 SOC 2 data center with fully redundant systems, failover and hourly backup, as well as secondary daily backup at a geographically distant data center, offering 99.9% uptime reliability with HIPAA-compliant level of data security and SSL encryption.
 
Every service plan option should come with a number of support hours. You have questions, especially when you're just getting to know a new system. Your support account should allow you to put in a ticket any time you need help, including emailing or calling them to talk to local, highly trained and experienced support staff.
 
 
Any provider should warranty (stand behind) all of their work for as long as you are our customer. Any customizations, setup or configurations they do should also be guaranteed, or work until things perform the way they're supposed to at no additional charge.

Revision as of 17:13, 14 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.

Sandbox begins below

4. Results Review and Verification

Regulation, Specification, or Guidance Requirement

21 CFR Part 211.68 (b)
42 CFR Part 493.1241
ASTM E1578-18 C-4-1
EPA ERLN Laboratory Requirements 4.9.11
EPA QA/G-5 2.4.1
ISO 15189:2012 5.5.1.4

4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.

ASTM E1578-18 C-4-2
EPA ERLN Laboratory Requirements 4.9.2
EPA ERLN Laboratory Requirements 4.9.11
EPA QA/G-5 2.4.1
ISO 15189:2012 5.9.2

4.2 The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.

21 CFR Part 211.68
21 CFR Part 211.100
21 CFR Part 211.160 (a)
21 CFR Part 211.188
21 CFR Part 211.194
45 CFR Part 170.315 (d)
ASTM E1578-18 C-4-3
CJIS Security Policy 5.4.1.1
EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7
E.U. Commission Directive 2003/94/EC Article 9.2
WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9

4.3 The system shall accurately maintain a full audit trail for modified results.

21 CFR Part 211.68 (b)
ABFT Accreditation Manual Sec. E-28–29
[AIHA-LAP Policies 2018 2A.7.7.2 and 7.7.3
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 5.9.4–5
ASTM E1578-18 C-4-4
EPA ERLN Laboratory Requirements 3.2.6
EPA ERLN Laboratory Requirements 4.9.2–3 and 4.9.11
EPA ERLN Laboratory Requirements 4.11.4
EPA QA/G-5 2.2.10
EPA QA/G-5 2.4.1
E.U. Annex 11-6
ISO 15189:2012 5.7.1
ISO/IEC 17025:2017 7.8.1.1
USDA Data and Instrumentation for PDP 10

4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results—whether entered manually or via an automated process—before release.

ASTM E1578-18 C-4-5
EPA ERLN Laboratory Requirements 4.9.11
EPA QA/G-5 2.2.10
EPA QA/G-5 2.4.1
E.U. Annex 11-6
ISO 15189:2012 5.9.2

4.5 The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.

ASTM E1578-18 C-4-6
EPA QA/G-5 2.2.10
EPA QA/G-5 2.4.1
E.U. Annex 11-6

4.6 The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.

5. Sample, Experiment, and Study Approval and Verification

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 C-5-1
USDA Sample Processing and Analysis Procedures for PDP 5.9–10 		5.1 The system shall accurately record details of a sample's final disposition.
AIHA-LAP Policies 2018 2A.7.7.2
ASTM E1578-18 C-5-2 		5.2 The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.
21 CFR Part 211.160 (b)
ASTM E1578-18 C-5-3
EPA 815-R-05-004 Chap. IV, Sec. 6.1 		5.3 The system should provide appropriate functions for specific sample statuses like "approved" and "rejected," including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.
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