Template:LIMSpec/Agriculture and food data management - Revision history

Shawndouglas: 19.7

2022-12-14T23:50:41Z

19.7

← Older revision		Revision as of 23:50, 14 December 2022
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	[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 5.1]<br />		[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 5.1]<br />
	[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.1]<br />		[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.1]<br />
			[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.8.2]<br />
	[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.5.4]<br />		[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.5.4]<br />
	[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4]<br />		[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4]<br />

Shawndouglas: Updated for food and bev update

2022-12-01T23:13:41Z

Updated for food and bev update

← Older revision		Revision as of 23:13, 1 December 2022
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	\| style="padding:5px; width:500px;" \|[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 5.4.12 and 5.4.14]		\| style="padding:5px; width:500px;" \|[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 5.4.12 and 5.4.14]
	\| style="background-color:white;" \|'''19.4''' The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list.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.		\| style="background-color:white;" \|'''19.4''' The system shall allow a site that is no longer active for sampling purposes be designated as inactive, yet be allowed to remain on any generated master list.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.
			\|-
			\| style="padding:5px; width:500px;" \|
			[https://www.law.cornell.edu/cfr/text/21/part-117 21 CFR Part 117.130–135]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-120 21 CFR Part 120 (throughout)]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-123 21 CFR Part 123.6]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-507 21 CFR Part 507, Subpart C]<br />
			[https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 417.x]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 2.x]<br />
			[https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf Codex Alimentarius CXC 1-1969, Ch.2, 3.x]<br />
			[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02004R0852-20210324 E.U. Commission Reg. No. 852/2004 Article 5]<br />
			[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02005R2073-20200308 E.U. Commission Reg. No. 2073/2005 Article 5]<br />
			[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - HACCP 1.X]<br />
			[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 2.2.x]<br />
			[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 2.2.x]<br />
			[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.4.3]<br />
			[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.4.3]<br />
			[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 2.4.3]
			\| style="background-color:white;" \|'''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.
			\|-
			\| style="padding:5px; width:500px;" \|[https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 417.4]
			\| style="background-color:white;" \|'''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.
			\|-
			\| style="padding:5px; width:500px;" \|
			[https://www.law.cornell.edu/cfr/text/21/part-106 21 CFR Part 106.90]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-106 21 CFR Part 106.92]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-106 21 CFR Part 106.94]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-106 21 CFR Part 106.100 (j)]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.4.x]<br />
			[https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 20]<br />
			[https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 5.1]<br />
			[https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.1]<br />
			[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.5.4]<br />
			[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.5.4]<br />
			[https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 2.5.4]
			\| style="background-color:white;" \|'''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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	\|}		\|}
	\|}		\|}

Shawndouglas: Updated for 2022.

2022-05-05T20:35:27Z

Updated for 2022.

← Older revision		Revision as of 20:35, 5 May 2022
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	! style="color:brown; background-color:#ffffee; width:700px;"\| Requirement		! style="color:brown; background-color:#ffffee; width:700px;"\| Requirement
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://~~elexnet~~.fda.gov/~~elex~~/documents/~~eLEXNET_DX_Brochure_Aug_2011~~.pdf FDA ~~eLEXNET~~ Data Exchange Program]		\| style="padding:5px; width:500px;" \|[https://orapartners.fda.gov/cs/groups/public/documents/document/b2hh/bmri/~edisp/rpohandbook.pdf FDA Office of Regulatory Affairs Data Exchange (ORA DX) Program]
	\| style="background-color:white;" \|'''19.1''' The system should be able to create or convert an XML or XLS file to ~~eLEXNET~~ template specifications, including the use of ~~eLEXNET~~ terminology.		\| style="background-color:white;" \|'''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.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 5.3]<br />[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.2]		\| style="padding:5px; width:500px;" \|[https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br />[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 5.3]<br />[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.2]
	\| style="background-color:white;" \|'''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.		\| style="background-color:white;" \|'''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.
	\|-		\|-

Shawndouglas: Created as needed.

2019-09-19T22:50:34Z

Created as needed.

New page

{|
| STYLE="vertical-align:top;"|
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
|-
! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
|-
| style="padding:5px; width:500px;" |[https://elexnet.fda.gov/elex/documents/eLEXNET_DX_Brochure_Aug_2011.pdf FDA eLEXNET Data Exchange Program]
| style="background-color:white;" |'''19.1''' The system should be able to create or convert an XML or XLS file to eLEXNET template specifications, including the use of eLEXNET terminology.
|-
| style="padding:5px; width:500px;" |[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 5.3]<br />[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.2]
| style="background-color:white;" |'''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.
|-
| style="padding:5px; width:500px;" |[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 5.4]
| style="background-color:white;" |'''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.
|-
| style="padding:5px; width:500px;" |[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 5.4.12 and 5.4.14]
| style="background-color:white;" |'''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.
|-
|}
|}