Product Detail:
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.
|
