Template:LIMS Selection Guide for Manufacturing Quality Control/Blank LIMSpec template for manufacturing labs/Specialty laboratory functions

A4. Specialty laboratory functions

Note: These categories cover the specialty requirements that come with working in specific industries such as agriculture, pharmaceutical production, and forensic science. You'll likely notice that most of the content here isn't covered by ASTM E1578-18.

17. Production management

Regulation, Specification, or Guidance Requirement 21 CFR Part 211.103 21 CFR Part 226.40 (d) WHO Technical Report Series, #986, Annex 2, 16.4 and 16.20 17.1 The system should be able to calculate and record theoretical and actual percentage of yield at various phases of processing, manufacturing, and packaging. 21 CFR Part 211.103 17.2 The system should provide a means for verification and approval of yield calculations before release for reporting. 21 CFR Part 820.20 21 CFR Part 820.40 21 CFR Part 820.186 E.U. Commission Directive 2003/94/EC Article 11 WHO Technical Report Series, #986, Annex 2, 1.0 17.3 The system shall be able to maintain a production facility's quality system in a specific quality system record, in accordance with regulations and guidance such as 21 CFR Part 820.20 and 820.40 (U.S.), E.U. Commission Directive 2003/94/EC Article 11 (E.U.), and WHO Technical Report Series, #986, Annex 2, 1.0 (global). 21 CFR Part 820.30 21 CFR Part 820.120 (e) 17.4 The system shall be able to create a design control document capable of recording the details surrounding device development, including control number, physical and performance requirements, final output, review, verification, approval, transfer, changes, and complete design history. 21 CFR Part 820.181 21 CFR Part 820.184 17.5 The system shall be able to create a device master and device history record capable of recording all information described in 21 CFR Part 820.181 and 820.184. 21 CFR Part 106.6 21 CFR Part 111.255–260 21 CFR Part 114.100 (b) 21 CFR Part 211.105 (b) 21 CFR Part 211.130 (e) 21 CFR Part 211.134 (c) 21 CFR Part 211.188 21 CFR Part 211.20 (d) 21 CFR Part 211.50 (c) 21 CFR Part 225.102 21 CFR Part 225.202 21 CFR Part 226.80 21 CFR Part 226.102 21 CFR Part 820.60 21 CFR Part 820.70 (a) 21 CFR Part 820.80 (c) 21 CFR Part 820.120 (d) BRC GSFS, Issue 8, 6.1.1 Codex Alimentarius CXC 1-1969, Ch.1, 7.1.1 Codex Alimentarius CXC 1-1969, Ch.1, 8.1 E.U. Commission Directive 2003/94/EC Article 9.1 FDA Hazard Analysis Critical Control Point Principle 2 and 4 FDA Hazard Analysis Critical Control Point Principle 7 GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11 IFS Food 7, Part 2, 4.2.1.1 IFS Food 7, Part 2, 4.18.1 IFS PACsecure 2, Part 2, 4.2.1.1 IFS PACsecure 2, Part 2, 4.18.1 Safe Food for Canadians Regulations SOR/2018-108 Division 3, 48 (3) SQF FSC 9, Food Manufacturing, Part B, 2.3.1–2 SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1–2 SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1–2 WHO Technical Report Series, #986, Annex 2, 2.1 (a) and (f–g) WHO Technical Report Series, #986, Annex 2, 15.25–30 17.6 The system shall be able to create a batch production record capable of recording complete information regarding batch production and control details such as, but not limited to, a unique batch, lot, or production run number; formulation; specific labeling and packaging; production steps; in-process and laboratory control results; the unique identifier of any equipment used; persons performing and/or supervising operational steps; and the results of any pre-process or post-production inspections. 21 CFR Part 106.6 21 CFR Part 106.100 (e) 21 CFR Part 111.205–210 21 CFR Part 114.100 (b) 21 CFR Part 211.186 21 CFR Part 212.50 (b) 21 CFR Part 225.102 21 CFR Part 226.102 BRC GSFS, Issue 8, 3.6.2 BRC GSFS, Issue 8, 9.2.1 Codex Alimentarius CXC 1-1969, Ch.1, 7.1.2 FDA Hazard Analysis Critical Control Point Principle 7 GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.1 GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 11 IFS Food 7, Part 2, 4.2.1.1 IFS PACsecure 2, Part 2, 4.2.1.1 SQF FSC 9, Food Manufacturing, Part B, 2.3.1–2 SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1–2 SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1–2 WHO Technical Report Series, #986, Annex 2, 15.22–23 17.7 The system shall be able to create a master production and control record capable of recording complete information regarding master production and control details. 21 CFR Part 106.100 (e) 21 CFR Part 111.123 (a) 21 CFR Part 114.100 (c) 21 CFR Part 117.150 (d) 21 CFR Part 211.100 21 CFR Part 211.186 21 CFR Part 212.50 (b) 61 FR 38806, 9 CFR Part 417.3 BRC GSFS, Issue 8, 9.2.4 E.U. Commission Directive 2003/94/EC Article 10.3–4 GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 10.2 IFS Food 7, Part 2, 4.2.1.2 IFS Food 7, Part 2, 4.3.x IFS Food 7, Part 2, 5.11 IFS PACsecure 2, Part 2, 4.2.1.2 IFS PACsecure 2, Part 2, 4.3.x IFS PACsecure 2, Part 2, 5.11 SQF FSC 9, Food Manufacturing, Part B, 2.3.1–2 SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1–2 SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1–2 WHO Technical Report Series, #986, Annex 2, 2.1 (a–b) WHO Technical Report Series, #986, Annex 2, 4.0 17.8 The system shall require a new or modified master production and control record to be validated, reviewed, and approved before being implemented into production, including allowing that record to be electronically signed by one or more authorized individuals upon approval. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity. 21 CFR Part 111.123 (a) 21 CFR Part 114.100 (c) 21 CFR Part 117.150 (d) 21 CFR Part 211.22 21 CFR Part 211.192 21 CFR Part 820.70 (b) 21 CFR Part 820.75 61 FR 38806, 9 CFR Part 417.3 E.U. Commission Directive 2003/94/EC Article 10.3 IFS Food 7, Part 2, 4.2.1.2 IFS Food 7, Part 2, 4.3.x IFS Food 7, Part 2, 5.11 IFS PACsecure 2, Part 2, 4.2.1.2 IFS PACsecure 2, Part 2, 4.3.x IFS PACsecure 2, Part 2, 5.11 SQF FSC 9, Food Manufacturing, Part B, 2.3.1–2 SQF FSC 9, Pet Food Manufacturing, Part B, 2.3.1–2 SQF FSC 9, Manufacture of Food Packaging, Part B, 2.3.1–2 WHO Technical Report Series, #986, Annex 2, 2.1 (a–b, f) WHO Technical Report Series, #986, Annex 2, 4.0 17.9 The system shall require a new or modified production and control record to be validated, reviewed, and approved before being implemented in production. If discrepancies or other errors are found, the system shall also allow authorized individuals to document corrective action taken to resolve those errors, including conclusions and follow-up activity. 21 CFR Part 211.110 21 CFR Part 212.50 21 CFR Part 820.80 (c) FDA Hazard Analysis Critical Control Point Principle 4 ISO/TS 22002-1:2009, 14.3 17.10 The system shall be able to indicate if a sample consists of an in-process manufacturing material and track characteristics of the in-process material such as identity, strength, quality, purity, and approval status. 21 CFR Part 211.111 17.11 The system shall provide a means to track the amount of time between production processes. 21 CFR Part 106.6 21 CFR Part 106.80 21 CFR Part 106.100 (f-6) 21 CFR Part 117.420 21 CFR Part 211.122 (c) 21 CFR Part 211.184 21 CFR Part 212.20 (b) 21 CFR Part 212.40 (c) and (e) 21 CFR Part 225.42 21 CFR Part 226.40 (b) 21 CFR Part 226.42 21 CFR Part 606.120 (b) 21 CFR Part 820.60 21 CFR Part 820.80 (b) 21 CFR Part 820.120 (b) BRC GSFS, Issue 8, 3.6.1 BRC GSFS, Issue 8, 3.9.2 BRC GSFS, Issue 8, 5.4.4 BRC GSFS, Issue 8, 3.5.1 BRC GSFS, Issue 8, 9.5.1–2 Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8 GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 14.1.1 GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.2 GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 14.1.3 GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17 IFS Food 7, Part 2, 4.5.2 IFS Food 7, Part 2, 4.18.1 IFS PACsecure 2, Part 2, 4.5.2 IFS PACsecure 2, Part 2, 4.18.1 ISO/TS 22002-1:2009, 9.3 ISO/TS 22002-1:2009, 14.2 ISO/TS 22002-4:2013, 4.6.3 ISO/TS 22002-4:2013, 4.11.2 ISO/TS 22002-6:2016, 4.6.3 ISO/TS 22002-6:2016, 4.11.2 Safe Food for Canadians Regulations SOR/2018-108 Part 5, 90 WHO Technical Report Series, #986, Annex 2, 14.4, 14.15, and 14.21 WHO Technical Report Series, #986, Annex 2, 15.32–33 17.12 The system shall be capable of documenting the receipt of non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, medical devices, labeling, and packaging materials), including information such as manufacturer, date of receipt, lot numbers, reference numbers, certificates of conformity, shelf life or expiration date, storage location, status of examination, and status of approval for use. Any related specifications for those materials should be able to be linked to the received materials. 21 CFR Part 211.122 (e) 21 CFR Part 211.125 (d) 21 CFR Part 211.184 21 CFR Part 225.42 21 CFR Part 226.42 BRC GSFS, Issue 8, 3.5.3 BRC GSFS, Issue 8, 9.5.3 Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8 GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 17 WHO Technical Report Series, #986, Annex 2, 14.7 and 14.22 WHO Technical Report Series, #986, Annex 2, 16.35 17.13 The system shall be capable of recording the changing quantity of inventoried non-sample, -standard, and -reagent materials (e.g., formulated drugs, drug components, raw ingredients, labeling, containers, and packaging materials), including batch and lot numbers and, if applicable, details of disposition after completion of production. 21 CFR Part 106.6 21 CFR Part 106.70 21 CFR Part 111.113 21 CFR Part 111.123 (b) 21 CFR Part 114.100 (d) 21 CFR Part 120.10 21 CFR Part 123.6 21 CFR Part 211.122 (e) 21 CFR Part 211.125 (d) 21 CFR Part 211.184 21 CFR Part 225.42 21 CFR Part 226.42 21 CFR Part 606.100 (c) 21 CFR Part 820.80 (d–e) 21 CFR Part 820.90 21 CFR Part 820.160 BRC GSFS, Issue 8, 3.8.1 Codex Alimentarius CXC 1-1969, Ch.1, 7.2.2 E.U. Commission Reg. No. 2073/2005 Article 7 GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 23 GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 24.1 IFS Food 7, Part 2, 5.7.1 IFS Food 7, Part 2, 5.10 IFS PACsecure 2, Part 2, 5.7.1 IFS PACsecure 2, Part 2, 5.10 Safe Food for Canadians Regulations SOR/2018-108 Division 5, 82–84 Safe Food for Canadians Regulations SOR/2018-108 Part 5, 90 SQF FSC 9, Food Manufacturing, Part B, 2.4.5 SQF FSC 9, Food Manufacturing, Part B, 2.4.7 SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.5 SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.7 SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.5 SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.7 WHO Technical Report Series, #986, Annex 2, 2.1 (g) WHO Technical Report Series, #986, Annex 2, 14.4, 14.26, and 14.28 WHO Technical Report Series, #986, Annex 2, 15.44–45 WHO Technical Report Series, #986, Annex 2, 16.36 WHO Technical Report Series, #986, Annex 2, 17.18–19 17.14 The system shall prevent the internal release for distribution of a completed production batch until an authorized individual has determined the batch's conformance to final specifications and has approved it for release. If a batch is nonconforming, the system shall be able to clearly document it as such (so as to not distribute it) and provide a review and disposition process. Such approval, rejection, review, and disposition activities shall be documented. 21 CFR Part 7 Subpart C 21 CFR Part 117.139 21 CFR Part 211.192 21 CFR Part 507.38 21 CFR Part 810 Subpart B BRC GSFS, Issue 8, 3.11.2 Codex Alimentarius CXC 1-1969, Ch.1, 7.5 E.U. Commission Directive 2003/94/EC Article 13 E.U. Commission Reg. No. 2073/2005 Article 7 GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 22 IFS Food 7, Part 2, 5.9.2 IFS PACsecure 2, Part 2, 5.9.2 ISO/TS 22002-1:2009, 15.x ISO/TS 22002-4:2013, 4.12 ISO/TS 22002-6:2016, 4.12 Safe Food for Canadians Regulations SOR/2018-108 Division 5, 82–84 SQF FSC 9, Food Manufacturing, Part B, 2.6.3 SQF FSC 9, Pet Food Manufacturing, Part B, 2.6.3 SQF FSC 9, Manufacture of Food Packaging, Part B, 2.6.3 WHO Technical Report Series, #986, Annex 2, 6.0 WHO Technical Report Series, #986, Annex 2, 14.32 17.15 The system shall provide a means to track and record recall activities of manufactured product and devices based on lot, batch, or other identifier, including storage location, necessary disposition details, and reconciliation between distributed and recovered quantities. 21 CFR Part 111.520 21 CFR Part 211.165 (f) 21 CFR Part 211.204 21 CFR Part 212.71 (d) 21 CFR Part 820.90 (b-2) E.U. Commission Reg. No. 2073/2005 Article 7 SQF FSC 9, Food Manufacturing, Part B, 2.4.6 SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.6 SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.6 WHO Technical Report Series, #986, Annex 2, 14.29–30 17.16 The system should allow a completed production batch that has been rejected for use or a returned production batch to be flagged in the system for reprocessing or reworking if it meets relevant criteria. 21 CFR Part 112.145 BRC GSFS, Issue 8, 4.11.8.x E.U. Commission Reg. No. 2073/2005 Article 5 GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, I - FSM 19.2 ISO/TS 22002-1:2009, 11.5 SQF FSC 9, Food Manufacturing, Part B, 2.4.8 SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.8 SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.8 17.17 The system shall support environmental testing protocols for testing the production environment on a scheduled, reportable basis. That support shall include facility and sampling site management functionality that allows for highlighting specific test points in the facility, as well as support for offsite and randomized testing. The system should also allow associated samples, methods, tests, reports, and other documents to clearly indicate they correspond to specific environmental testing protocols.

18. Statistical trending and control charts

Regulation, Specification, or Guidance Requirement 21 CFR Part 820.250 AIHA-LAP Policies 2018 2A.7.7.1.3 ASTM E1578-18 E-10-1 EPA 815-R-05-004 Chap. IV, Sec. 7.2.8 EPA 815-R-05-004 Chap. VI, Sec. 7.8 E.U. Commission Reg. No. 2073/2005 Article 9 FDA Hazard Analysis Critical Control Point Principle 4 ISO/IEC 17025:2017 7.7.1 18.1 The system should allow authorized users to configure the generation of statistical trending and control charts. 21 CFR Part 820.250 AIHA-LAP Policies 2018 2A.7.7.1.3 ASTM E1578-18 E-10-2 EPA 815-R-05-004 Chap. IV, Sec. 7.2.8 EPA 815-R-05-004 Chap. VI, Sec. 7.8 E.U. Commission Reg. No. 2073/2005 Article 9 FDA Hazard Analysis Critical Control Point Principle 4 18.2 The system should allow authorized users to choose specific sample types, tests, and parameters associated with the statistical trending and control charts that can be generated.

19. Agriculture and food data management

Regulation, Specification, or Guidance Requirement FDA Office of Regulatory Affairs Data Exchange (ORA DX) Program 19.1 The system should be able to create or convert an XML or XLS file to ORA DX template specifications, including the use of ORA DX terminology. PFP Human and Animal Food Testing Laboratories Best Practices Manual USDA Sampling Procedures for PDP 5.3 USDA Sampling Procedures for PDP 6.2 19.2 The system shall allow for the assignment of the "regulatory sample collection" role and be able to produce a list of individuals in said role, including information such as name, locations assigned, part- or full-time role, and full-time equivalents (if any) used to meet any regulatory requirements. USDA Sampling Procedures for PDP 5.4 19.3 The system shall allow for the documentation of sampling sites used for normal and regulatory sampling and be able to produce a complete list of such sites on-demand. The documentation should allow for details such as the addition of a unique, never-before-used site code; a region code; demographics; date added to or removed from the system; facility type; sample substrates or commodities available at the site; and relative volume information. USDA Sampling Procedures for PDP 5.4.12 and 5.4.14 19.4 The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list. Additionally, such inactive site shall maintain its unique site number in the event the site becomes reinstated as active. 21 CFR Part 117.130–135 21 CFR Part 120 (throughout) 21 CFR Part 123.6 21 CFR Part 507, Subpart C 61 FR 38806, 9 CFR Part 417.x BRC GSFS, Issue 8, 2.x Codex Alimentarius CXC 1-1969, Ch.2, 3.x E.U. Commission Reg. No. 852/2004 Article 5 E.U. Commission Reg. No. 2073/2005 Article 5 GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - HACCP 1.X IFS Food 7, Part 2, 2.2.x IFS PACsecure 2, Part 2, 2.2.x SQF FSC 9, Food Manufacturing, Part B, 2.4.3 SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.3 SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.3 19.5 The system shall allow for the development and documentation of hazard analysis and critical control points (HACCP) or other regulatory-driven food safety plan steps, as well as the implementation of those CCPs or steps into configurable laboratory workflow. 61 FR 38806, 9 CFR Part 417.4 19.6 The system shall require a new or modified HACCP or other regulatory-driven food safety plan be validated, reviewed, and approved before being implemented, including requiring that plan to be electronically signed by one or more authorized individuals upon approval. 21 CFR Part 106.90 21 CFR Part 106.92 21 CFR Part 106.94 21 CFR Part 106.100 (j) BRC GSFS, Issue 8, 3.4.x GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 20 IFS Food 7, Part 2, 5.1 IFS PACsecure 2, Part 2, 5.1 ISO/IEC 17025:2017 8.8.2 SQF FSC 9, Food Manufacturing, Part B, 2.5.4 SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4 SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.4 19.7 The system shall allow for the documentation and management of internal and external audit activities, while allowing samples, methods, tests, results, reports, documents, and more to be clearly associated with that corresponding audit activity.

20. Environmental data management

Not relevant to food and beverage labs.

21. Forensic case and data management

Not relevant to food and beverage labs.

22. Clinical and public health data management

Not relevant to food and beverage labs.

23. Veterinary data management

Not relevant to food and beverage labs.

24. Scientific data management

Regulation, Specification, or Guidance Requirement ASTM E1578-18 E-11-1 EPA ERLN Laboratory Requirements 4.3.4.1 EPA ERLN Laboratory Requirements 4.8.9 EPA ERLN Laboratory Requirements 4.9.9 24.1 The system shall capture raw instrument data and metadata either as an electronic file or directly via RS-232 or TCP/IP communication. ASTM E1578-18 E-11-2 24.2 The scientific data management system (SDMS) should provide a checksum verification of source and destination data and store that verification data in a secure server with controlled access. ASTM E1578-18 E-11-1 EPA ERLN Laboratory Requirements 4.3.4.1 EPA ERLN Laboratory Requirements 4.8.9 EPA ERLN Laboratory Requirements 4.9.9 24.3 The system shall store metadata related to raw instrument data in a database in such a way that the original data generated by instruments for specific samples and tests is easy to retrieve. ASTM E1578-18 E-11-4 24.4 The system should be capable of capturing a complete and readable copy of original data and any previous versions of modified data in order to maintain the integrity of that data. AAVLD AAVLD Requirements for an AVMDL Sec. 4.10.2.3 ASTM E1578-18 E-11-5 EPA ERLN Laboratory Requirements 4.3.4.1 EPA ERLN Laboratory Requirements 4.8.9 EPA ERLN Laboratory Requirements 4.9.9 24.5 The system should secure raw data such that it can't be deleted and provide version control when data is modified by any user or specific software. ASTM E1578-18 E-11-6 24.6 The SDMS should provide tools for helping a laboratory achieve the U.S. Food and Drug Administration's defined ALCOA principles. ASTM E1578-18 E-11-7 24.7 The SDMS shall provide security and access controls for protecting stored data. ASTM E1578-18 E-11-8 24.8 The SDMS shall record an audit trail for each and every record created and modified, using version control. 45 CFR Part 164.308 ASTM E1578-18 E-11-9 24.9 The SDMS shall provide proper systems for backing up, restoring, and archiving data for long-term use.

25. Health information technology

Not relevant to food and beverage labs.