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| Regulation, Specification, or Guidance
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Requirement
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| FDA Office of Regulatory Affairs Data Exchange (ORA DX) Program
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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.
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PFP Human and Animal Food Testing Laboratories Best Practices Manual
USDA Sampling Procedures for PDP 5.3
USDA Sampling Procedures for PDP 6.2
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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.
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| USDA Sampling Procedures for PDP 5.4
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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.
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| USDA Sampling Procedures for PDP 5.4.12 and 5.4.14
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19.4 The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list.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.
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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
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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.
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| 61 FR 38806, 9 CFR Part 417.4
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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.
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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
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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.
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