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

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.”