|
|
| 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 instrument type, sample types tested, and laboratory location.
|
|
▪ 21 CFR Part 110.40 (f)
▪ 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
▪ A2LA C211 5.5.2
▪ A2LA C223 5.5
▪ AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2
▪ AAVLD Requirements for an AVMDL Sec. 5.5
▪ ABFT Accreditation Manual Sec. E-20
▪ ACMG Technical Standards for Clinical Genetics Laboratories C1.5
▪ ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.6.1.1
▪ AIHA-LAP Policies 2022 2C.3.7–2C.3.10
▪ ASTM E1578-18 E-3-7
▪ BRC GSFS, Issue 8, 6.4.x
▪ CAP Laboratory Accreditation Manual
▪ CLSI QMS22 2.6.1
▪ 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
▪ GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2
▪ GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19
▪ IFS Food 7, Part 2, 5.4.2
▪ IFS PACsecure 2, Part 2, 5.4.2
▪ ISO 15189:2012 5.3.1.4
▪ ISO/IEC 17025:2017 6.4.7
▪ ISO/IEC 17025:2017 6.4.8
▪ ISO/TS 22002-4:2013, 4.7.1
▪ ISO/TS 22002-6:2016, 4.7
▪ NIST 800-53, Rev. 5, MA-2 and MA-2(2)
▪ SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1
▪ SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1
▪ SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1
▪ USDA Administrative Procedures for the PDP 5.2.4
▪ USDA Data and Instrumentation for PDP 5.2
▪ USDA Data and Instrumentation for PDP 6
▪ WADA International Standard for Laboratories (ISL) 5.2.4
▪ WHO Technical Report Series, #986, Annex 2, 13.5
▪ WHO Technical Report Series, #986, Annex 2, 16.23
|
10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for—as well as the manual and automatic scheduling of calibration or maintenance of—equipment, instruments, and systems. Available intervals should include 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
▪ BRC GSFS, Issue 8, 6.4.x
▪ GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2
▪ IFS Food 7, Part 2, 5.4.2
▪ IFS PACsecure 2, Part 2, 5.4.2
▪ 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)
▪ A2LA C211 5.5.7
▪ A2LA C223 5.6
▪ ABFT Accreditation Manual Sec. E-21
▪ ASTM E1578-18 E-3-9
▪ BRC GSFS, Issue 8, 6.4.x
▪ CLSI QMS22 2.1.2.1
▪ IFS Food 7, Part 2, 5.4.3
▪ IFS PACsecure 2, Part 2, 5.4.3
▪ ISO 15189:2012 5.3.1.5
▪ ISO/IEC 17025:2017 6.4.4
▪ ISO/IEC 17025:2017 6.4.9
▪ NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
▪ SQF FSC 9, Food Manufacturing, Part B, 11.2.3.4
▪ SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.4
▪ SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.4
▪ TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5.7)
▪ 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, while preventing it from being selected for use.
|
|
▪ 21 CFR Part 111.117
▪ 21 CFR Part 820.72 (b-2)
▪ ASTM E1578-18 E-3-10
▪ BRC GSFS, Issue 8, 6.4.x
▪ EPA ERLN Laboratory Requirements 4.11.11–13
▪ EPA QA/G-5 2.2.6–7
▪ ISO/IEC 17025:2017 6.4.8
▪ NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-6(1)
▪ 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
▪ A2LA C211 5.6.2.1
▪ A2LA C223 5.6
▪ AAVLD Requirements for an AVMDL Sec. 5.6.1–2
▪ AIHA-LAP Policies 2022 2C.3.7 and Appendix H5.1-5.3
▪ BRC GSFS, Issue 8, 6.4.x
▪ EPA 815-R-05-004 Chap. IV, Sec. 7
▪ GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.2
▪ ISO/IEC 17025:2017 6.4.13
▪ ISO/IEC 17025:2017 6.5
▪ ISO/TS 22002-4:2013, 4.7.1
▪ ISO/TS 22002-6:2016, 4.7
▪ OECD GLP Principles 4.2
▪ SQF FSC 9, Food Manufacturing, Part B, 11.2.3.2
▪ SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.2
▪ SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.2
▪ TNI EL-V1-2016-Rev.2.1 (V1,M2 5.6.2.1 and 5.6.4.1)
▪ 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 110.40 (f)
▪ 21 CFR Part 211.105 (b)
▪ 42 CFR Part 493.1255
▪ A2LA C211 5.5.4 and 5.5.5
▪ AAVLD Requirements for an AVMDL Sec. 5.5.4–5
▪ ASTM E1578-18 E-3-12
▪ BRC GSFS, Issue 8, 6.4.x
▪ EPA 815-R-05-004 Chap. IV, Sec. 7
▪ EPA QA/G-5 2.2.6–7
▪ GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 17.1
▪ IFS Food 7, Part 2, 5.4.1
▪ IFS PACsecure 2, Part 2, 5.4.1
▪ ISO 15189:2012 5.3.1.7
▪ ISO/IEC 17025:2017 6.4.8
▪ ISO/IEC 17025:2017 6.4.13
▪ NIST 800-53, Rev. 5, CM-8
▪ NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
▪ SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6
▪ SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6
▪ SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6
▪ TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)
▪ USDA Administrative Procedures for the PDP 7.2
▪ USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4j
▪ WADA International Standard for Laboratories (ISL) 4.2.1 and 5.2.4
▪ WHO Technical Report Series, #961, Annex 13, 6.1
|
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
|
10.14 The system shall be able to automatically take a parent instrument offline when a child instrument or component goes offline.
|
|
▪ 10 CFR Part 20.2103
▪ 21 CFR Part 58.63
▪ 21 CFR Part 111.117
▪ 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
▪ A2LA C211 4.13.2.1
▪ A2LA C211 5.5.2
▪ A2LA C211 5.10.4
▪ 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 2022 2C.3.7–2C.3.10
▪ ASTM E1578-18 E-3-14
▪ CAP Laboratory Accreditation Manual
▪ CLSI QMS22 2.2.2.1
▪ 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
▪ GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 19
▪ IFS Food 7, Part 2, 5.4.2
▪ IFS PACsecure 2, Part 2, 5.4.2
▪ ISO 15189:2012 5.3.1.4
▪ ISO/IEC 17025:2017 6.4.4–5
▪ ISO/IEC 17025:2017 6.4.13
▪ NIST 800-53, Rev. 5, MA-2, MA-2(2), and MA-4
▪ NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards
▪ OECD GLP Principles 4.2
▪ SQF FSC 9, Food Manufacturing, Part B, 11.2.3.1
▪ SQF FSC 9, Food Manufacturing, Part B, 11.2.3.6
▪ SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.1
▪ SQF FSC 9, Pet Food Manufacturing, Part B, 4.2.3.6
▪ SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.1
▪ SQF FSC 9, Manufacture of Food Packaging, Part B, 13.2.3.6
▪ TNI EL-V1-2016-Rev.2.1 (V1,M2 5.5)
▪ USDA Administrative Procedures for the PDP 5.2.4
▪ USDA Data and Instrumentation for PDP 5.4
▪ USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4c
▪ WADA International Standard for Laboratories (ISL) 5.2.4
▪ WHO Technical Report Series, #986, Annex 2, 15.46
▪ WHO Technical Report Series, #986, Annex 2, 16.23
|
10.15 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.
|
|
