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"

Reviewed by John E. Lincoln, principal, J. E. Lincoln with US FDA personnel at local and CDRH

as acceptable for general software validations

For Software: 1) In-product; 2) As-product; 3) Process; 4) QMS (21 CFR Part 11-compliant)

Software V&V is risk-based

  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 and Validation)  *
  10.  Revision History and Release Number
  11.  Unresolved Anomalies ('Bugs')
  
*  Key documents involved in traceability and in verifying 
understanding of the software and its V&V.  

21 CFR Part 11: Electronic Records and Electronic Signatures:

[To review FDA's 21 CFR Part 11 Guidance,click 21 CFR Part 11 Guidance]

  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

Medical Devices / Pharmaceuticals / Quality / Regulatory Affairs

For additional information and/or to request matrices of the above, at no charge, please... CONTACT US