Some thoughts on Requirements … using the General Principles of Software Validation to help.
Many times we struggle with creating software requirements and documenting them. The FDA General Principles of Software Validation-Final Guidance helps set the FDA expectations in this area. Section 4.1 of the guidance states:
“A documented software requirements specification provides a baseline for both validation and verification. The software validation process cannot be completed without an established software requirements specification (Ref: 21 CFR 820.3(z) and (aa) and 820.30(f) and (g)).”
“Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.
- Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
- Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).”
Final thought: Notice the word “baseline.” One should be sure to understand the baseline software requirements for any external release of software. Plan how the baselines will be managed and associated configuration management activities.