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| Regulation, Specification, or Guidance
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Requirement
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| ▪ ASTM E1578-18 E-17-1
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22.1 System functionality should support ALCOA principles.
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▪ ASTM E1578-18 E-17-2
▪ EPA 815-R-05-004 Chap. IV, Sec. 8
▪ EPA ERLN Laboratory Requirements 4.8.6
▪ EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7
▪ NIST 800-53, Rev. 4, SI-12
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22.2 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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▪ ASTM E1578-18 E-17-3
▪ 21 CFR Part 58.190
▪ EPA 815-R-05-004 Chap. IV, Sec. 8
▪ EPA ERLN Laboratory Requirements 4.3.4.1
▪ EPA ERLN Laboratory Requirements 4.8.6
▪ EPA ERLN Laboratory Requirements 4.8.9
▪ EPA ERLN Laboratory Requirements 4.9.9
▪ NIST 800-53, Rev. 4, SI-12
▪ OECD GLP Principles 10
▪ USDA Administrative Procedures for the PDP 5.2.1
▪ USDA Data and Instrumentation for PDP 8.1.3
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22.3 The system shall maintain a true, readable copy of an instrument's original (raw) data for on-demand review.
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▪ 7 CFR Part 331.17 (c)
▪ 9 CFR Part 121.17 (c)
▪ 21 CFR Part 11.10 (c)
▪ 21 CFR Part 58.195
▪ 21 CFR Part 211.180
▪ 21 CFR Part 212.110 (c)
▪ 21 CFR Part 225.42 (b-8)
▪ 21 CFR Part 225.58 (c–d)
▪ 21 CFR Part 225.102
▪ 21 CFR Part 225.110
▪ 21 CFR Part 225.158
▪ 21 CFR Part 225.202
▪ 21 CFR Part 226.42 (a)
▪ 21 CFR Part 226.58 (f)
▪ 21 CFR Part 226.102
▪ 21 CFR Part 226.115
▪ 21 CFR Part 312.57
▪ 21 CFR Part 312.62
▪ 21 CFR Part 606.160 (d)
▪ 21 CFR Part 812.140 (d)
▪ 21 CFR Part 820.180 (b)
▪ 29 CFR Part 1910.1030 (h-2)
▪ 40 CFR Part 141.33
▪ 40 CFR Part 141.722
▪ 40 CFR Part 704 Subpart A
▪ 40 CFR Part 717.15 (d)
▪ 42 CFR Part 73.17 (c)
▪ 42 CFR Part 493.1105
▪ 42 CFR Part 493.1283
▪ 45 CFR Part 164.105
▪ 45 CFR Part 164.316
▪ 45 CFR Part 164.530
▪ AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1
▪ AAVLD Requirements for an AVMDL Sec. 4.10.1.2
▪ AAVLD Requirements for an AVMDL Sec. 4.10.2.1
▪ AAVLD Requirements for an AVMDL Sec. 5.4.3.2
▪ ABFT Accreditation Manual Sec. E-33
▪ AIHA-LAP Policies 2018 2A.7.5.1
▪ ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2
▪ ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7
▪ ASTM E1578-18 E-17-4
▪ CJIS Security Policy 5.3.4
▪ CJIS Security Policy 5.4.6–7
▪ CJIS Security Policy 5.5.2.1
▪ E.U. Annex 11-7.1
▪ E.U. Commission Directive 2003/94/EC Article 9.1
▪ E.U. Commission Directive 2003/94/EC Article 11.4
▪ EPA 815-R-05-004 Chap. III, Sec. 15
▪ EPA 815-R-05-004 Chap. IV, Sec. 8
▪ EPA ERLN Laboratory Requirements 4.9.18
▪ EPA ERLN Laboratory Requirements 4.11.17
▪ EPA QA/G-5 2.1.9
▪ ISO 15189:2012 4.3
▪ ISO/IEC 17025:2017 8.4.2
▪ NIST 800-53, Rev. 4, AT-4
▪ NIST 800-53, Rev. 4, AU-11 and AU-11(1)
▪ NIST 800-53, Rev. 4, SI-12
▪ OECD GLP Principles 10
▪ USDA Administrative Procedures for the PDP 5.4
▪ USDA Sampling Procedures for PDP 6.5
▪ WHO Technical Report Series, #986, Annex 2, 15.8–9
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22.4 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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▪ ASTM E1578-18 E-17-6
▪ CJIS Security Policy 5.4.4
▪ NIST 800-53, Rev. 4, AU-8
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22.5 The system shall accurately reflect the system date and time in its use of electronic record time stamps.
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▪ ASTM E1578-18 E-17-7
▪ CJIS Security Policy 5.6.1
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22.6 The system shall require each and every user to be assigned a unique user ID.
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▪ ASTM E1578-18 E-17-8
▪ 21 CFR Part 11.10 (e)
▪ CJIS Security Policy 5.4.5
▪ E.U. Annex 11-9
▪ NIST 800-53, Rev. 4, AU-9
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22.7 The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.
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▪ CJIS Security Policy 5.4.2
▪ NIST 800-53, Rev. 4, AU-5
▪ NIST 800-53, Rev. 4, SI-4
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22.8 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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