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10. Instrument and Equipment Management

Regulation, Specification, or Guidance Requirement ASTM E1578-18 E-3-1 10.1 The system should provide a means for tracking usage of laboratory equipment and instruments. ASTM E1578-18 E-3-2 10.2 The system shall provide a means for planning the use of and reserving equipment and instruments. ASTM E1578-18 E-3-3 10.3 The system shall be able to bring an instrument online and take an instrument offline both manually and via a configurable scheduler. ASTM E1578-18 E-3-4 10.4 The system should record instrument usage time to assist laboratory personnel with capacity planning and scheduling. ASTM E1578-18 E-3-5 10.5 The system shall allow users to configure and record multiple instrument events for the same instrument, including different event types and different frequencies for the same event type. ASTM E1578-18 E-3-6 10.6 The system shall be able to group instruments together in specific ways, including by type and laboratory location. 21 CFR Part 211.67–68 21 CFR Part 211.160 (b-4) 21 CFR Part 212.30 (b) 21 CFR Part 212.60 (e) 21 CFR Part 225.30 (b-4) 21 CFR Part 606.60 21 CFR Part 820.70 (g) 21 CFR Part 820.72 42 CFR Part 493.1252 (b-3) 42 CFR Part 493.1255 AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2 AAVLD Requirements for an AVMDL Sec. 5.5 ABFT Accreditation Manual Sec. E-20 ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1 AIHA-LAP Policies 2018 2C.3.7–2C.3.10 ASTM E1578-18 E-3-7 EPA 815-R-05-004 Chap. IV, Sec. 7 EPA ERLN Laboratory Requirements 4.11.11–13 EPA QA/G-5 2.2.6–7 ISO 15189:2012 5.3.1.4 ISO/IEC 17025:2017 6.4.7 ISO/IEC 17025:2017 6.4.8 USDA Administrative Procedures for the PDP 5.2.4 USDA Data and Instrumentation for PDP 5.2 USDA Data and Instrumentation for PDP 6 WHO Technical Report Series, #986, Annex 2, 13.5 WHO Technical Report Series, #986, Annex 2, 16.23 10.7 The system shall allow the configuration of calibration and maintenance frequency and time frames, with available intervals of days, weeks, months, and years. 21 CFR Part 225.30 (b-4) AAVLD Requirements for an AVMDL Sec. 5.5.9 ASTM E1578-18 E-3-8 WHO Technical Report Series, #986, Annex 2, 16.23 10.8 The system shall provide clear alerts or notifications when an instrument nears its calibration due date. 21 CFR Part 211.160 (b-4) ABFT Accreditation Manual Sec. E-21 ASTM E1578-18 E-3-9 ISO 15189:2012 5.3.1.5 ISO/IEC 17025:2017 6.4.9 WHO Technical Report Series, #986, Annex 2, 13.10 10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use. 21 CFR Part 820.72 (b-2) ASTM E1578-18 E-3-10 EPA ERLN Laboratory Requirements 4.11.11–13 EPA QA/G-5 2.2.6–7 ISO/IEC 17025:2017 6.4.8 WHO Technical Report Series, #986, Annex 2, 16.23 10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument. 21 CFR Part 820.72 (b-1) 42 CFR Part 493.1255 AAVLD Requirements for an AVMDL Sec. 5.6.1–2 AIHA-LAP Policies 2018 2C.3.7 EPA 815-R-05-004 Chap. IV, Sec. 7 ISO/IEC 17025:2017 6.5 OECD GLP Principles 4.2 USDA Data and Instrumentation for PDP 6.1 10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes. ASTM E1578-18 E-3-11 10.12 The system shall support the use of predefined intervals when calculating Instrument event dates. 21 CFR Part 211.105 (b) 42 CFR Part 493.1255 AAVLD Requirements for an AVMDL Sec. 5.5.4–5 ASTM E1578-18 E-3-12 EPA 815-R-05-004 Chap. IV, Sec. 7 EPA QA/G-5 2.2.6–7 ISO 15189:2012 5.3.1.7 ISO/IEC 17025:2017 6.4.8 ISO/IEC 17025:2017 6.4.13 USDA Administrative Procedures for the PDP 7.2 10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information—such as manufacturer, model number, serial number, and calibration and maintenance history—within the system. ASTM E1578-18 E-3-13 10.13 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline. 21 CFR Part 58.63 21 CFR Part 211.67–68 21 CFR Part 211.160 (b-4) 21 CFR Part 211.182 21 CFR Part 211.194 (d) 21 CFR Part 212.30 (b) 21 CFR Part 212.60 (e) 21 CFR Part 820.70 (g) 21 CFR Part 820.72 42 CFR Part 493.1254 42 CFR Part 493.1255 AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2 AAVLD Requirements for an AVMDL Sec. 5.5 ABFT Accreditation Manual Sec. E-20 and -23 ABFT Accreditation Manual Sec. F-1 and I-1 AIHA-LAP Policies 2018 2C.3.7–2C.3.10 ASTM E1578-18 E-3-14 EPA 815-R-05-004 Chap. IV, Sec. 7 EPA ERLN Laboratory Requirements 4.11.11–13 EPA QA/G-5 2.2.6–7 ISO 15189:2012 5.3.1.4 ISO/IEC 17025:2017 6.4.4 OECD GLP Principles 4.2 USDA Administrative Procedures for the PDP 5.2.4 USDA Data and Instrumentation for PDP 5.4 WHO Technical Report Series, #986, Annex 2, 15.46 WHO Technical Report Series, #986, Annex 2, 16.23 10.14 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.

11. Batch and Lot Management

Regulation, Specification, or Guidance Requirement 21 CFR Part 58.105 (a) 21 CFR Part 211.80 21 CFR Part 225.102 21 CFR Part 226.102 ASTM E1578-18 E-4-1 EPA ERLN Laboratory Requirements 3.3 EPA ERLN Laboratory Requirements 4.10.1 OECD GLP Principles 6.2 11.1 The system shall provide a means for organizing samples or processes into identifiable batches based upon pre-defined criteria. 21 CFR Part 211.80 21 CFR Part 225.102 21 CFR Part 226.102 ASTM E1578-18 E-4-2 EPA ERLN Laboratory Requirements 4.10.1 11.2 The system shall maintain the links between component parts of a batch and track the batch throughout the system. 21 CFR Part 211.80 21 CFR Part 225.102 21 CFR Part 226.102 21 CFR Part 820.65 ASTM E1578-18 E-4-3 11.3 The system shall allow for identifying a batch as a unique entity that can be quality controlled in the same way as, e.g., a single sample. ASTM E1578-18 E-4-4 11.4 The system should provide a means for determining the effectiveness of a process and designate the disposition of a batch based on study or experiment results. E.U. Annex 11-15 11.5 The system shall allow only authorized personnel to certify the release of batches, requiring an electronic signature to do so.