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Computer Software Assurance, sized to the risk
For QA and IT teams that want to stop over-documenting low-risk functions and focus effort where patient safety and data integrity are at stake. We apply FDA's Computer Software Assurance guidance and GAMP 5 (Second Edition) principles in practice, so you get less paperwork and assurance you can defend.
The problem
Traditional validation often documents low-risk functions as heavily as critical ones. The result is stacks of scripted evidence that are rarely read again, while the real risks to data integrity and product quality can go unexamined.
Regulators have said for years that assurance should be risk-based. Even so, many organizations still work the old way, because changing procedures, habits and culture is hard.
Computer Software Assurance doesn't mean less testing. It means testing in the right places: critical functions get thorough, scripted assurance, and the rest gets lighter, documented activities with a recorded rationale.
What we deliver
Whether you're starting from nothing or modernizing what you have.
- CSA program build, from scratchValidation policy, governance and roles, a GxP system inventory with impact assessments, and a roadmap to bring systems under control.
- SOP and template developmentA complete SOP set covering CSA lifecycle, risk assessment, supplier assessment, change control, periodic review and data integrity, with templates and training.
- Assurance plans and risk assessmentsIntended use, function-level risk and a documented rationale for the level of assurance each function gets.
- Requirements traceabilityLean links from requirements to risk, testing and evidence, sized to the system rather than to a template.
- IQ / OQ / PQ executionScripted testing where risk warrants it and unscripted or exploratory testing where it doesn't, with every result recorded.
- Assurance Summary Reports and periodic reviewConcise fitness-for-use conclusions, plus reviews that keep systems in a controlled state as they change.
- CSV to CSA transitionAlready have CSV procedures? We redesign your SOPs, templates, change control and training around risk-based thinking.
- Data integrity and audit trail reviewCritical data definitions, audit trail functionality checks and risk-based review procedures.
How risk drives the work
Each risk level maps to a default set of assurance activities. That mapping is the core of a CSA program.
Our lifecycle| Risk | Typical assurance |
|---|---|
| High | Scripted testing with predefined acceptance criteria, and independent review |
| Medium | Unscripted or scenario-based testing with documented objectives and recorded results |
| Low | Reliance on vendor evidence and configuration verification, with the rationale recorded |
A note on the guidance
FDA's Computer Software Assurance guidance is formally written for medical device production and quality management system software. Pharmaceutical and biologics companies widely apply its risk-based principles as well, and GAMP 5 (Second Edition) supports the same thinking. Your program should say which framework it applies and on what basis. We help you set that out clearly.
Starting a CSA program, or changing one?
Tell us where you are. We'll suggest a right-sized place to start.