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

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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