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| Regulation, Specification, or Guidance
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Requirement
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21 CFR Part 312.62 (b)
21 CFR Part 812.140 (a-3)
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16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.
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21 CFR Part 312.57 (a)
21 CFR Part 312.62 (a)
21 CFR Part 606.165
21 CFR Part 812.140 (a-2) and (b-2)
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16.2 The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.
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21 CFR Part 58.81 (a)
21 CFR Part 211.100
21 CFR Part 211.111
21 CFR Part 211.192
21 CFR Part 211.194
21 CFR Part 606.171
42 CFR Part 493.1253 (b-2)
ABFT Accreditation Manual C-16
ABFT Accreditation Manual F-2
ABFT Accreditation Manual J-3
ASTM E1578-18 E-9-1
EPA ERLN Laboratory Requirements 3.3
EPA QA/G-5 2.2.4
ISO/IEC 17025:2017 7.2.1.7
ISO/IEC 17025:2017 7.2.2.1
ISO/IEC 17025:2017 7.10.2
ISO/IEC 17025:2017 8.7.1
OECD GLP Principles 7.3
USDA Administrative Procedures for the PDP 8.2.2
WHO Technical Report Series, #986, Annex 2, 16.3
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16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.
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42 CFR Part 493.1282
ASTM E1578-18 E-9-2
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16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.
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21 CFR Part 606.100 (c)
42 CFR Part 493.1282
ASTM E1578-18 E-9-3
EPA QA/G-5 2.2.10
WHO Technical Report Series, #986, Annex 2, 17.12
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16.5 The system should trigger an alert or notification when an OOS/OOT status is found, prompting a documented investigation to identify the root cause.
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21 CFR Part 225.58 (d)
21 CFR Part 225.158
21 CFR Part 606.100 (c)
21 CFR Part 820.100
42 CFR Part 493.1282
ASTM E1578-18 E-9-4
E.U. Commission Directive 2003/94/EC Article 13
FDA Hazard Analysis Critical Control Point Principle 5
New York Department of Health ELAP Microbiology Protocol
NIST 800-53, Rev. 4, IR-5
WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)
WHO Technical Report Series, #986, Annex 2, 5.0
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16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.
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21 CFR Part 225.58 (d)
21 CFR Part 225.158
42 CFR Part 493.1282
42 CFR Part 493.1289
ASTM E1578-18 E-9-5
CJIS Security Policy 5.3.4
CJIS Security Policy Appendix G.7
E.U. Commission Directive 2003/94/EC Article 13
FDA Hazard Analysis Critical Control Point Principle 5
New York Department of Health ELAP Microbiology Protocol
NIST 800-53, Rev. 4, AU-6(1)
NIST 800-53, Rev. 4, IR-4(1) and IR-5
NIST 800-53, Rev. 4, SI-2 and SI-4
WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)
WHO Technical Report Series, #986, Annex 2, 5.0
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16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.
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| ASTM E1578-18 E-9-6
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16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization’s standard operating procedures.
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