LII:LIMSpec/Maintaining Laboratory Workflow and Operations

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Note: These categories cover what ASTM E1578-18 considers to be the extended functions that support the previously described core laboratory workflow, from scheduling, batch/lot management, and instrument management to standard/reagent management and investigation management.

7. Document management

Regulation, Specification, or Guidance Requirement

7 CFR Part 331 (throughout)
9 CFR Part 121 (throughout)
21 CFR Part 7 (throughout)
21 CFR Part 58 (throughout)
21 CFR Part 211 (throughout)
21 CFR Part 212 (throughout)
21 CFR Part 225 (throughout)
21 CFR Part 226 (throughout)
21 CFR Part 312 (throughout)
21 CFR Part 606 (throughout)
21 CFR Part 810 (throughout)
21 CFR Part 812 (throughout)
21 CFR Part 820 (throughout)
29 CFR Part 1910.134 (throughout)
29 CFR Part 1910.1030 (throughout)
29 CFR Part 1910.1200 (throughout)
29 CFR Part 1910.1450 (throughout)
42 CFR Part 73 (throughout)
42 CFR Part 493.1200
42 CFR Part 493.1232
42 CFR Part 493.1239
42 CFR Part 493.1251
42 CFR Part 493.1291 (j)
45 CFR Part 164 (throughout)
AAFCO QA/QC Guidelines for Feed Laboratories (throughout)
AAVLD Requirements for an AVMDL (throughout)
ABFT Accreditation Manual (throughout)
ASTM E1188-11 3.5.2
ASTM E1492-11 4.3.3.3 and 4.4.4
ASTM E1578-18 D-1-1
CJIS Security Policy (throughout)
EPA 815-R-05-004 (throughout)
EPA ERLN Laboratory Requirements (throughout)
EPA QA/G-5 (throughout)
E.U. Commission Directive 2003/94/EC (throughout)
FDA Hazard Analysis Critical Control Point (throughout)
ISO 15189:2012 4.3
ISO 15189:2012 5.5.3
ISO 15189:2012 5.9.3
ISO/IEC 17025:2017 5.3
ISO/IEC 17025:2017 5.5
ISO/IEC 17025:2017 8.3.2
NIST 800-53, Rev. 4 (throughout)
OECD GLP Principles 8
USDA Administrative Procedures for the PDP (throughout)
USDA Data and Instrumentation for PDP (throughout)
USDA Sample Processing and Analysis Procedures for PDP (throughout)
WHO Technical Report Series, #986, Annex 2 (throughout)

7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.

7 CFR Part 331 (throughout)
9 CFR Part 121 (throughout)
21 CFR Part 7 (throughout)
21 CFR Part 58 (throughout)
21 CFR Part 211 (throughout)
21 CFR Part 212 (throughout)
21 CFR Part 225 (throughout)
21 CFR Part 226 (throughout)
21 CFR Part 312 (throughout)
21 CFR Part 606 (throughout)
21 CFR Part 810 (throughout)
21 CFR Part 812 (throughout)
21 CFR Part 820 (throughout)
29 CFR Part 1910.134 (c)
29 CFR Part 1910.1030 (throughout)
29 CFR Part 1910.1200 (e)
29 CFR Part 1910.1450 (throughout)
42 CFR Part 73 (throughout)
42 CFR Part 493.1200
42 CFR Part 493.1232
42 CFR Part 493.1239
42 CFR Part 493.1251
42 CFR Part 493.1291 (j)
42 CFR Part 493.1773 (c–d)
45 CFR Part 160.310
45 CFR Part 164 (throughout)
AAFCO QA/QC Guidelines for Feed Laboratories (throughout)
AAVLD Requirements for an AVMDL (throughout)
ASTM E1188-11 3.5.2
ASTM E1492-11 4.3.3.3 and 4.4.4
ASTM E1578-18 D-1-2
CJIS Security Policy (throughout)
EPA 815-R-05-004 (throughout)
EPA ERLN Laboratory Requirements (throughout)
EPA QA/G-5 (throughout)
E.U. Commission Directive 2003/94/EC (throughout)
FDA Hazard Analysis Critical Control Point (throughout)
ISO 15189:2012 (throughout)
ISO/IEC 17025:2017 (throughout)
NIST 800-53, Rev. 4 (throughout)
OECD GLP Principles 8
USDA Administrative Procedures for the PDP (throughout)
USDA Data and Instrumentation for PDP (throughout)
USDA Sample Processing and Analysis Procedures for PDP (throughout)
WHO Technical Report Series, #986, Annex 2 (throughout)

7.2 The system shall have the ability to readily provide access to electronic documents such as standard operating procedures, quality manuals, instrument manuals, information exchange agreements, and other applicable documents to designated personnel and officials.

21 CFR Part 820.40 (a)
42 CFR Part 493.1251 (e)
AAVLD Requirements for an AVMDL Sec. 4.3
ASTM E1578-18 D-1-3
EPA 815-R-05-004 Chap. III, Sec. 11
EPA ERLN Laboratory Requirements 4.2.4.2
EPA QA/G-5 2.1.9
ISO 15189:2012 4.3
ISO 15189:2012 5.5.3
ISO 15189:2012 5.9.3
ISO/IEC 17025:2017 7.5.2
ISO/IEC 17025:2017 8.3.2
USDA Administrative Procedures for the PDP 5.5
WHO Technical Report Series, #986, Annex 2, 15.5

7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.
ASTM E1578-18 D-1-4 7.4 The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.

21 CFR Part 211.21 (c)
21 CFR Part 212.20 (c)
21 CFR Part 212.60 (c)
21 CFR Part 226.58 (e)
21 CFR Part 820.250 (b)
42 CFR Part 493.43 (c)
ASTM E1578-18 D-1-5
EPA 815-R-05-004 Chap. IV, Sec. 5
ISO/IEC 17025:2017 6.5
ISO/IEC 17025:2017 7.2.1.3
USDA Administrative Procedures for the PDP 8.4
WHO Technical Report Series, #986, Annex 2, 15.14

7.5 The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.

21 CFR Part 212.20 (c)
21 CFR Part 212.70 (b)
AAVLD Requirements for an AVMDL Sec. 5.4.2.4
ABFT Accreditation Manual Sec. G-12, -14, and -15
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.5.4
EPA QA/G-5 2.2.4
ISO/IEC 17025:2017 7.2.2.1
USDA Administrative Procedures for the PDP 8.4
WHO Technical Report Series, #986, Annex 2, 4.11
WHO Technical Report Series, #986, Annex 2, 15.13

7.6 The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.

7 CFR Part 331.10
7 CFR Part 331.15
9 CFR Part 121.10
9 CFR Part 121.15
21 CFR Part 11.10 (i)
21 CFR Part 58.29
21 CFR Part 211.25
21 CFR Part 225.10
21 CFR Part 226.10
21 CFR Part 226.40
21 CFR Part 820.25
29 CFR Part 1910.134 (c)
29 CFR Part 1910.1030 (g-2)
29 CFR Part 1910.1030 (h-2)
29 CFR Part 1910.1200 (h)
29 CFR Part 1910.1450 (f)
42 CFR Part 73.10
42 CFR Part 73.15
42 CFR Part 493.43 (c)
42 CFR Part 493.1235
42 CFR Part 493.1251
45 CFR Part 164.308
45 CFR Part 164.530
AAFCO QA/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6
AAVLD Requirements for an AVMDL Sec. 5.2
AAVLD Requirements for an AVMDL Sec. 5.4.2.2
AAVLD Requirements for an AVMDL Appendix 1
ABFT Accreditation Manual Sec. B
AIHA-LAP Policies 2018 (various parts)
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1–3
ASTM E1578-18 C-3-5
ASTM E1578-18 D-1-6
ASTM E1578-18 E-1-6
E.U. Annex 11-2
E.U. Commission Directive 2003/94/EC Article 7.4
EPA 815-R-05-004 Chap. III, Sec. 10 and 17
EPA 815-R-05-004 Chap. IV, Sec. 1
EPA QA/G-5 2.1.8
ISO 15189:2012 4.1.2.1
ISO 15189:2012 5.1.6
ISO 15189:2012 5.1.9
ISO/IEC 17025:2017 6.2.2
ISO/IEC 17025:2017 6.2.3
ISO/IEC 17025:2017 6.2.5
ISO/IEC 17025:2017 6.2.6
OECD GLP Principles 1.1.2
USDA Administrative Procedures for the PDP 6.1

7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.
ASTM E1578-18 D-1-7 7.8 The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.
AAVLD Requirements for an AVMDL Sec. 4.3.4 and 4.3.5
EPA ERLN Laboratory Requirements 4.10.6
7.9 The system shall support the addition of accurate cross-references and page numbers to new documents.
AAVLD Requirements for an AVMDL Sec. 4.3.4 7.10 The system shall be capable of uniquely identifying documents created in and added to the system.

8. Resource management

Regulation, Specification, or Guidance Requirement

29 CFR Part 1910.120
29 CFR Part 1910.134 (m)
29 CFR Part 1910.1030 (h-1)
29 CFR Part 1910.1450 (j)
CJIS Security Policy 5.2.3
EPA ERLN Laboratory Requirements 4.2.4.1
EPA QA/G-5 2.1.8
NIST 800-53, Rev. 4, AT-4
USDA Administrative Procedures for the PDP 6.1
USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3

8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.

21 CFR Part 820.198
42 CFR Part 493.1233
E.U. Commission Directive 2003/94/EC Article 13
WHO Technical Report Series, #986, Annex 2, 2.1 (j)
WHO Technical Report Series, #986, Annex 2, 5.0

8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.

5 CFR Part 930.301
7 CFR Part 331.15
9 CFR Part 121.15
21 CFR Part 211.25
29 CFR Part 1910.1450 (f)
42 CFR Part 73.15
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3
ASTM E1578-18 E-1-1
CJIS Security Policy 5.2.1
EPA ERLN Laboratory Requirements 4.2.4.1
FDA Hazard Analysis Critical Control Point Guidelines
NIST 800-53, Rev. 4, AT-2 and AT-3
NIST 800-53, Rev. 4, CP-3
NIST 800-53, Rev. 4, IR-2
USDA Sampling Procedures for PDP 6.1.2–3
WHO Technical Report Series, #986, Annex 2, 10

8.3 The system shall allow training sessions to be scheduled for personnel.

5 CFR Part 930.301
29 CFR Part 1910.1450 (f)
ABFT Accreditation Manual Sec. B
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7
ASTM E1578-18 E-1-2
FDA Hazard Analysis Critical Control Point Guidelines

8.4 The system should provide access to relevant training materials to personnel attending training sessions.

5 CFR Part 930.301
29 CFR Part 1910.1450 (f)
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1–3
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5
ASTM E1578-18 E-1-3
CJIS Security Policy 5.2.3
EPA ERLN Laboratory Requirements 4.2.4.1
EPA QA/G-5 2.1.8
E.U. Commission Directive 2003/94/EC Article 7.4
FDA Hazard Analysis Critical Control Point Guidelines
ISO 15189:2012 5.1.9
NIST 800-53, Rev. 4, AT-2–AT-4
NIST 800-53, Rev. 4, CP-3
NIST 800-53, Rev. 4, IR-2
USDA Administrative Procedures for the PDP 6.1
USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3
WHO Technical Report Series, #986, Annex 2, 2.1 (e)
WHO Technical Report Series, #986, Annex 2, 9.4
WHO Technical Report Series, #986, Annex 2, 10

8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.
ABFT Accreditation Manual Sec. B
ASTM E1578-18 E-1-4
8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.
ASTM E1578-18 E-1-5

NIST 800-53, Rev. 4, AT-2 and AT-3
NIST 800-53, Rev. 4, CP-3
NIST 800-53, Rev. 4, IR-2

8.7 The system should be able to produce a training matrix of personnel.

7 CFR Part 331.15
9 CFR Part 121.10
9 CFR Part 121.15
21 CFR Part 11.10 (i)
21 CFR Part 58.29
21 CFR Part 211.25
21 CFR Part 225.10
21 CFR Part 226.10
21 CFR Part 226.40
21 CFR Part 820.25
29 CFR Part 1910.1030 (g-2)
29 CFR Part 1910.1030 (h-2)
29 CFR Part 1910.1200 (h)
29 CFR Part 1910.1450 (e)
42 CFR Part 73.10
42 CFR Part 73.15
42 CFR Part 493.43 (c)
42 CFR Part 493.1235
45 CFR Part 164.308
45 CFR Part 164.530
AAFCO QA/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6
AAVLD Requirements for an AVMDL Sec. 5.2
AAVLD Requirements for an AVMDL Sec. 5.4.2.2
AAVLD Requirements for an AVMDL Appendix 1
ABFT Accreditation Manual Sec. B
AIHA-LAP Policies 2018 (various parts)
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1–3
ASTM E1578-18 C-3-5
ASTM E1578-18 D-1-6
ASTM E1578-18 E-1-6
E.U. Annex 11-2
EPA 815-R-05-004 Chap. III, Sec. 10 and 17
EPA 815-R-05-004 Chap. IV, Sec. 1
EPA QA/G-5 2.1.8
ISO 15189:2012 4.1.2.1
ISO 15189:2012 5.1.6
ISO 15189:2012 5.1.9
ISO/IEC 17025:2017 6.2.2
ISO/IEC 17025:2017 6.2.3
ISO/IEC 17025:2017 6.2.5
ISO/IEC 17025:2017 6.2.6
OECD GLP Principles 1.1.2
USDA Administrative Procedures for the PDP 6.1

8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.

9. Compliance management

Regulation, Specification, or Guidance Requirement

7 CFR Part 331.17
9 CFR Part 121.17
21 CFR Part 11.10 (e)
21 CFR Part 11.70
21 CFR Part 58.130 (e)
42 CFR Part 73.17
42 CFR Part 493.1251 (d)
ASTM E1578-18 C-4-7
ASTM E1578-18 E-2-1
EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7
E.U. Annex 11-9
E.U. Annex 11-14
OECD GLP Principles 8.3.5
USDA Data and Instrumentation for PDP 8.1.3

9.1 The system shall accurately and consistently capture and add a time and date to created electronic records, as well as any modifications made to them. The system shall also prompt the user to enter a mandatory reason for any change made to a record.

21 CFR Part 11.10 (e)
21 CFR Part 11.70
21 CFR Part 58.130 (e)
21 CFR Part 211.68
21 CFR Part 211.100
21 CFR Part 211.160 (a)
21 CFR Part 211.188
21 CFR Part 211.194
45 CFR Part 170.315 (d)
ASTM E1578-18 E-2-2
CJIS Security Policy 5.4.1.1
CJIS Security Policy Appendix G.5
EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7
E.U. Annex 11-9
E.U. Annex 11-12.4
E.U. Annex 11-14
E.U. Commission Directive 2003/94/EC Article 9.2
NIST 800-53, Rev. 4, AC-2(4) and AC-6(9)
NIST 800-53, Rev. 4, AU-2 and AU-3
NIST 800-53, Rev. 4, CM-5(1)
OECD GLP Principles 8.3.5
WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9

9.2 The system shall document in the audit trail any event—including administrative and privileged functions—that creates, modifies, and deletes data, including user accounts, passwords, files, directories, logs, and other system resources.

21 CFR Part 11.10 (e)
21 CFR Part 11.70
21 CFR Part 58.130 (e)
21 CFR Part 211.68
21 CFR Part 211.100
21 CFR Part 211.160 (a)
21 CFR Part 211.188
21 CFR Part 211.194
42 CFR Part 493.1274
45 CFR Part 170.315 (d)
ASTM E1578-18 E-2-3
CJIS Security Policy 5.4.1.1
E.U. Annex 11-12.4
E.U. Annex 11-14
E.U. Commission Directive 2003/94/EC Article 9.2
NIST 800-53, Rev. 4, AU-3 and AU-8
OECD GLP Principles 8.3.5
USDA Data and Instrumentation for PDP 8.1.4
WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9

9.3 The system's audit trail shall document the date, time, and user associated with a given event, as well as whether the event succeeded or failed.

21 CFR Part 11.10 (e)
21 CFR Part 11.70
21 CFR Part 58.130 (e)
21 CFR Part 211.68
21 CFR Part 211.100
21 CFR Part 211.160 (a)
21 CFR Part 211.188
21 CFR Part 211.194
45 CFR Part 170.315 (d)
ASTM E1578-18 E-2-4
EPA ERLN Laboratory Requirements 4.8.6
E.U. Annex 11-14
E.U. Commission Directive 2003/94/EC Article 9.2
NIST 800-53, Rev. 4, AU-3
OECD GLP Principles 8.3.5
WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9

9.4 The system's audit trail shall document the previous and current value of a modified field.

21 CFR Part 11.10 (e)
21 CFR Part 11.70
21 CFR Part 58.130 (e)
21 CFR Part 211.194
42 CFR Part 493.1251 (d)
45 CFR Part 164.310
ASTM E1578-18 E-2-5
EPA ERLN Laboratory Requirements 4.8.6
E.U. Annex 11-14
OECD GLP Principles 8.3.5

9.5 The system shall provide electronic signature support to users who require the review, approval, rejection, modification, or disposition of a record.
21 CFR Part 11.70
E.U. Annex 11-14
9.6 The system shall prevent a user from copying and pasting the electronic signature of another user.

21 CFR Part 11.10 (e)
21 CFR Part 58.130 (e)
42 CFR Part 493.1274 (d)
E.U. Annex 11-9
NIST 800-53, Rev. 4, AU-6 and AU-12
OECD GLP Principles 8.3.5

9.7 The system shall be able to generate a complete and accurate copy of the audit trail in a human-readable and printable format.

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
NIST 800-53, Rev. 4, MA-2 and MA-2(2)
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 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 be 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
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
NIST 800-53, Rev. 4, 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
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
NIST 800-53, Rev. 4, CM-8
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 10.14 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
NIST 800-53, Rev. 4, MA-2, MA-2(2), and MA-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

10.15 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.

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.

12. Scheduled event management

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 E-5-1
USDA Sampling Procedures for PDP 5.6–7
12.1 The system shall allow users to create, maintain, and revise schedules for various laboratory tasks and processes.
21 CFR Part 212.61 (a)
21 CFR Part 211.166 (b)
ASTM E1578-18 E-5-2
12.2 The system scheduler shall be capable of working with a variety of laboratory tasks like calibrations, maintenance, and stability studies.
ASTM E1578-18 E-5-3 12.3 The system scheduler shall automatically create a sample number specifically for recording the results of calibration, validation, and maintenance.
ASTM E1578-18 E-5-4 12.4 The system shall be capable of handling industry-specific testing characteristics (e.g., sampling points, human body sampling location).
ASTM E1578-18 E-5-5 12.5 The system shall provide a means for setting a standard or reagent's retest date based on a retest interval.

13. Instrument data capture and control

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 E-6-1 13.1 The system shall be able to trigger an instrument event after a definable number of uses of that instrument.
ASTM E1578-18 E-6-2 13.2 The system shall be able to automatically take an instrument offline when an instrument's calibration or maintenance date passes without calibration or maintenance taking place.
ASTM E1578-18 E-6-3 13.3 The system should allow auto samplers and other robotic systems to be controlled via an application programming interface or web services.
ASTM E1578-18 E-6-4 13.4 The system should accurately record instrument information, personnel names, dates, and times relating to entered results or determinations.
ASTM E1578-18 E-6-5 13.5 The system should be able to accept the results uploaded from an interfaced instrument.
ASTM E1578-18 E-6-6 13.6 The system should be capable of sending sample sequences (e.g., control samples, standards) to an instrument that is bidirectionally interfaced.
ASTM E1578-18 E-6-7 13.7 The system should provide a means to interface with simple laboratory instruments using technologies such as RS-232, TCP/IP, and USB.
ASTM E1578-18 E-6-8 13.8 The system should support industry communication standards like Specification E1394 and Health Level 7 for bidirectional communication with laboratory instrumentation software.

14. Standard and reagent management

Regulation, Specification, or Guidance Requirement

21 CFR Part 58.83
29 CFR Part 1910.1200 (g)
29 CFR Part 1910.1450 (h)
42 CFR Part 493.1252 (c)
ABFT Accreditation Manual Sec. E-17
ASTM E1578-18 E-7-1
ISO 15189:2012 5.3.2.4–5
OECD GLP Principles 4.4

14.1 The system shall allow for accurate inventory management of all standards, reagents, and consumables used for laboratory testing. The system shall also be able to link manufacturer documents such as material safety data sheets and in-house instructions to their respective materials.

7 CFR Part 331.3
9 CFR Part 121.3
21 CFR Part 312.58 (b)
42 CFR Part 73.3–4 (c)
ASTM E1578-18 E-7-2
EPA ERLN Laboratory Requirements 4.1.12
ISO 15189:2012 5.3.2.4
WHO Technical Report Series, #986, Annex 2, 12.20

14.2 The inventory system shall allow a material to be clearly identified as a controlled, regulated, or hazardous substance and flagged based on its physical and/or chemical stability.
ASTM E1578-18 E-7-3
ISO 15189:2012 5.3.2.4
14.3 The system shall be capable of tracking standard and reagent consumption and expiration such that a list of items nearing reorder level or expiration date can be produced on demand.
ASTM E1578-18 E-7-4
ISO 15189:2012 5.3.2.4
14.4 The system should be capable of tracking standards and volumetric solutions created in-house such that concentration, purity, and molarity factor are recorded and made available during calculation of results.
ASTM E1578-18 E-7-5
ISO 15189:2012 5.3.2.4
14.5 The system shall be capable of applying review statuses to a standard or reagent's properties, also requiring additional review if properties such as vendor lot number or expiration date are changed.

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
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

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
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

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.