Our Recommended 11 Elements of A Software V&V Report,
Based on the FDA's "model" -- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices , especially Table 3 on documentation required.
Reviewed by John E. Lincoln, principal, J. E. Lincoln and Associates LLC, with U.S. FDA personnel at the local post (SLC UT) and CDRH (Rockville MD) as acceptable as a general software validation documentation "model" (the 11 elements, Table 3), for all regulated industries.
For Software: 1) In-product; 2) As-product; 3) Process; 4) QMS (21 CFR Part 11-compliant).
Software V&V is risk-based (recommend principles of ISO 14971 / ICH Q9 for product risk documentation contents).
The 11 Element SW Documentation Model:
01. Level of Concern
02. Hazard/Risk Analysis *
03. Software Description
04. SRS (Software Requirements Specification) *
05. Architecture
06. Design Specification
07. Traceability (Matrix; Paragraph Numbering)*
08. Development
09. V&V (Verification/Testing & Validation: IQ, OQ, Pt 11 test cases, if required, PQs)*
10. Unresolved Anomalies ('Bugs')
11. Revision History and Release Number
* Key documents involved in traceability (by matrix and/or common numbers) and in
verifying understanding of the software and developing its V&V test cases / scrip.
21 CFR Part 11: Electronic Records and Electronic Signatures:
[To review FDA's 21 CFR Part 11 Guidance, click 21 CFR Part 11 Guidance]
Use when e-records and/or e-signatures are used to make CGMP decisions or records.
Part 11 insures that e-records / signatures have the same integrity, accuracy, retainability, etc., as paper records, manual signatures.
Subpart A -- General Provisions
11.1 Scope
11.2 Implementation
11.3 Definitions
Subpart B -- Electronic Records
11.10 Controls for Closed Systems
11.30 Controls for Open Systems
11.50 Signature Manifestations
Subpart C -- Electronic Signatures
11.100 General Requirements
11.200 Electronic Signature Components and Controls
11.300 Controls for Identification Codes/Passwords
John E. Lincoln, principal consultant, J. E. Lincoln and Associates LLC
Medical Devices / Pharmaceuticals / Quality / Regulatory Affairs
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