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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19.4 The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list.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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