J. E. Lincoln and Associates LLC                                                     435-840-0252

P. O. Box 2786                                                                          

St. George  UT  84771-2786                                                      jel@jelincoln.com 

www.jelincoln.com                    "Business success from regulatory compliance"(TM)



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

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

                                                                                                                          Last updated on 04/13/2023.