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FDA OTS SW STD CK/L

2012 Edition, January 10, 2012

Complete Document

SOFTWARE ENGINEERING PROCESS TECHNOLOGY-EVIDENCE PRODUCT CHECKLIST FOR THE FDA DOCUMENT: “FDA 21 CFR PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES; FINAL RULE”



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Product Details:

  • Revision: 2012 Edition, January 10, 2012
  • Published Date: January 4, 2012
  • Status: Active, Most Current
  • Document Language: English
  • Published By: Software Engineering Process Technology (SEPT)
  • Page Count: 22
  • ANSI Approved: No
  • DoD Adopted: No

Description / Abstract:

Document Number - SEPT FDA INDUSTRY GUIDANCE Software Engineering Process Technology - Evidence Product Checklist for the FDA Document: "Guidance For Industry, FDA Reviewers and Compliance On Off-The-Shelf Software Use In Medical Devices" As Amended By: "Guidance for Industry, FDA Reviewers and Compliance On Cybersecurity for Networked Medical Devices Containing Off-The Shelf (OTS) Software" The experts at SEPT have updated Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices to reflect the suggested compliance with the document Compliance on Cyersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software dated January 14, 2005. This checklist reflects these new requirements. The Checklist provides an easy-to-use classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. The Checklist clarifies what is required for compliance through a product evidence list that will assist any software organization in meeting the requirements of this guideline.