FDA, General Principles of Software Validation Final Guidance for Industry and FDA Staff (Release date January 11, 2002)

As amended by Guidance for Industry, FDA Reviewers and Compliance on Cyber security for Networked Medical Devices Containing Off-the Shelf (OTS) Software, January 14, 2005

Abstract: Available
Author: Stan Magee CCP (Ret.)
Cover: Available
Customer Set for this product: Medical Device Firms
Format: Word® (To save money, click here for our PDF version)
ISBN Numbers: 978-0-9716087-3-3 / 0-9716087-3-3
Language: English
Page count of document: 110
Provider: SEPT
Sample Pages: Available
Shipping: Available for download - Link will be provided in My ComplianceOnline section

Price: $330.00
Product Details

The experts at SEPT have produced a checklist for this major software engineering standard "General Principles of Software Validation" - Final Guidance for Industry and FDA staff.

The Checklist uses a classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews.

The Checklist clarifies what is required for compliance by providing an easy-to-use product evidence list that will assist any software organization in meeting the requirements of this standard .

General Principles of Software Validation Checklist:

This checklist was prepared by analyzing each clause of this draft document for the key words that signify a:

  • Policy
  • Procedure
  • Plan
  • Records
  • Document (Including Manuals, Reports, Scripts and Specifications)
  • Audit
  • Review

This checklist specifies evidence that is software or system unique.

This product supports these Software Engineering processes

  • Acquisition
  • Code and Test
  • Configuration Management
  • Documentation
  • Life cycle
  • Quality
  • Verification and Validation

Customers of this product:

  • Baxter.
  • Capintec
  • Carolinas Medical Center
  • Cellnovo Ltd.
  • CINCI. Italy
  • Corning Inc
  • Eradlink
  • Evaheart, Japan
  • Hhmpvascular.
  • Logikos
  • Lumina Engineering
  • Medicept, Inc.
  • Medtronic
  • Nutramax Labs
  • Power Vision Inc
  • QIAGEN GmbH, Germany
  • Shiseido
  • Uptake Medical

Note: “International Standards (ISO) define the best of practices for Medical Device and Software firms in producing a quality product. This checklist that SEPT produces will ensure that all of the best of practices are adhered to.”

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