View source for LIMSpec/Data integrity

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  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
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  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-1]
  | style="background-color:white;" |'''31.1''' System functionality should support ALCOA principles.
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[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-2]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.6]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7]
  | style="background-color:white;" |'''31.2''' The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.
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[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-3]<br />
[https://www.law.cornell.edu/cfr/text/21/58.190 21 CFR Part 58.190]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.4.1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.6]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.9]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.9]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.2.1]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.3]
  | style="background-color:white;" |'''31.3''' The system shall maintain a true, readable copy of an instrument's original (raw) data for on-demand review.
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[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17 (c)]<br />
[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/58.195 21 CFR Part 58.195]<br />
[https://www.law.cornell.edu/cfr/text/21/211.180 21 CFR Part 211.180]<br />
[https://www.law.cornell.edu/cfr/text/21/211.110 21 CFR Part 212.110 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/225.42 21 CFR Part 225.42 (b-8)]<br />
[https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58 (c–d)]<br />
[https://www.law.cornell.edu/cfr/text/21/225.102 21 CFR Part 225.102]<br />
[https://www.law.cornell.edu/cfr/text/21/225.110 21 CFR Part 225.110]<br />
[https://www.law.cornell.edu/cfr/text/21/225.158 21 CFR Part 225.158]<br />
[https://www.law.cornell.edu/cfr/text/21/225.202 21 CFR Part 225.202]<br />
[https://www.law.cornell.edu/cfr/text/21/226.42 21 CFR Part 226.42 (a)]<br />
[https://www.law.cornell.edu/cfr/text/21/226.58 21 CFR Part 226.58 (f)]<br />
[https://www.law.cornell.edu/cfr/text/21/226.102 21 CFR Part 226.102]<br />
[https://www.law.cornell.edu/cfr/text/21/226.115 21 CFR Part 226.115]<br />
[https://www.law.cornell.edu/cfr/text/21/312.57 21 CFR Part 312.57]<br />
[https://www.law.cornell.edu/cfr/text/21/312.62 21 CFR Part 312.62]<br />
[https://www.law.cornell.edu/cfr/text/21/606.160 21 CFR Part 606.160 (d)]<br />
[https://www.law.cornell.edu/cfr/text/21/812.140 21 CFR Part 812.140 (d)]<br />
[https://www.law.cornell.edu/cfr/text/21/820.180 21 CFR Part 820.180 (b)]<br />
[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/40/141.33 40 CFR Part 141.33]<br />
[https://www.law.cornell.edu/cfr/text/40/141.722 40 CFR Part 141.722]<br />
[https://www.law.cornell.edu/cfr/text/40/part-704/subpart-A 40 CFR Part 704 Subpart A]<br />
[https://www.law.cornell.edu/cfr/text/40/717.15 40 CFR Part 717.15 (d)]<br />
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17 (c)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1105 42 CFR Part 493.1105]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1283 42 CFR Part 493.1283]<br />
[https://www.law.cornell.edu/cfr/text/45/164.105 45 CFR Part 164.105]<br />
[https://www.law.cornell.edu/cfr/text/45/164.316 45 CFR Part 164.316]<br />
[https://www.law.cornell.edu/cfr/text/45/164.530 45 CFR Part 164.530]<br />
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.10.1.2]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 4.10.2.1]<br />
[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.3.2]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-33]<br />
[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.5.1]<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 4.14.1.2 and 4.15.1.2]<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 5.9.3.6 and 5.9.7]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-4]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.3.4]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.6–7]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.5.2.1]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-7.1]<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 9.1]<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 11.4]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 15]<br />
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 8]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.18]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.17]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.9]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 4.3]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.4.2]<br />
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 10]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.4]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.5]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.8–9]
  | style="background-color:white;" |'''31.4''' The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.
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  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-6]<br />[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.4]
  | style="background-color:white;" |'''31.5''' The system shall accurately reflect the system date and time in its use of electronic record time stamps.
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  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-7]<br />[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.6.1]
  | style="background-color:white;" |'''31.6''' The system shall require each and every user to be assigned a unique user ID.
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[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-17-8]<br />
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (e)]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.5]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-9]
  | style="background-color:white;" |'''31.7''' The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.
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  | style="padding:5px; width:500px;" |[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.2]
  | style="background-color:white;" |'''31.8''' The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.
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