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15. Inventory Management

Regulation, Specification, or Guidance Requirement ASTM E1578-18 E-8-1 15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples. 21 CFR Part 212.60 (d) ASTM E1578-18 E-8-2 15.2 The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date. 21 CFR Part 211.84 21 CFR Part 211.101 21 CFR Part 212.60 (d) 21 CFR Part 226.80 21 CFR Part 606.120 (b) 29 CFR Part 1910.1030 (g) 29 CFR Part 1910.1096 (e-6) 29 CFR Part 1910.1200 (f-6) and (f-10) ASTM E1578-18 E-8-3 WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41 WHO Technical Report Series, #986, Annex 2, 15.10–12 15.3 The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories. 21 CFR Part 212.40 (c) 21 CFR Part 820.50 ASTM E1578-18 E-8-4 USDA Administrative Procedures for the PDP 7.1 WHO Technical Report Series, #986, Annex 2, 14.8 15.4 The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation. 21 CFR Part 211.196 21 CFR Part 212.90 21 CFR Part 225.110 21 CFR Part 606.165 29 CFR Part 1910.1450 Appendix A (I) ASTM E1578-18 E-8-5 15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials. 21 CFR Part 211.82 (b) 21 CFR Part 211.84 (a) 21 CFR Part 211.89 21 CFR Part 211.110 (d) 21 CFR Part 211.142 (a) 21 CFR Part 212.40 (c) ASTM E1578-18 E-8-6 WHO Technical Report Series, #986, Annex 2, 12.18 15.6 The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of. 21 CFR Part 211.89 21 CFR Part 211.110 (d) 42 CFR Part 493.1252 (d) ASTM E1578-18 E-8-7 15.7 The system should allow authorized personnel to retire faulty or poor quality materials from use. 21 CFR Part 211.89 ASTM E1578-18 E-8-8 15.8 The system shall clearly designate a standard or reagent as being disposed or consumed.

16. Investigation Management

Regulation, Specification, or Guidance Requirement 21 CFR Part 312.62 (b) 21 CFR Part 812.140 (a-3) 16.1 The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed. 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) 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. 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 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. 42 CFR Part 493.1282 ASTM E1578-18 E-9-2 16.4 The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents. 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 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. 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 WHO Technical Report Series, #986, Annex 2, 2.1 (f, j) WHO Technical Report Series, #986, Annex 2, 5.0 16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance. 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 WHO Technical Report Series, #986, Annex 2, 2.1 (f, j) WHO Technical Report Series, #986, Annex 2, 5.0 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. ASTM E1578-18 E-9-6 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.