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Consulting for computerized software assurance

Computer Software Assurance, proportional to risk. We help life sciences teams prove their computerized systems are fit for intended use. We build programs from scratch, support single system changes, run programs of work, and take AI initiatives from scoping through release.

Our lifecycle

  1. Intended use
  2. Risk assessment
  3. Assurance plan
  4. Testing
  5. Summary report
  6. Periodic review
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Computer Software Assurance

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.

  • CSA program build, from scratch. Policy, governance and roles, a GxP system inventory with impact assessments, and a roadmap.
  • SOP and template development. A complete SOP set with templates and training.
  • Assurance plans and risk assessments. Function-level risk with a documented rationale.
  • Requirements traceability. Lean links from requirements to risk, testing and evidence.
  • IQ / OQ / PQ execution. Scripted where risk warrants it, unscripted where it doesn't.
  • Summary reports and periodic review. Concise fitness-for-use conclusions.
  • CSV to CSA transition. SOPs, templates, change control and training redesigned around risk.
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AI in GxP

For teams adopting AI or LLM tools in regulated work who need them to hold up as GxP computerized systems. AI brings risks traditional validation wasn't designed for: outputs that aren't fully deterministic, model drift, vendor updates and hallucination. We apply GAMP 5 Appendix D11 so AI-enabled systems can be assured and governed like any other GxP system.

  • Intended use and risk classification. What the AI does, what it supports, and where a human stays accountable.
  • Platform, hybrid API or custom build. The track that fits, with its supplier, control and testing obligations.
  • Audit trail, human review and e-signatures. Controls aligned to 21 CFR Part 11 and EU Annex 11.
  • Assurance testing. Reference sets, adversarial inputs, consistency checks and hallucination stress tests.
  • Model governance. Monitoring, change control for model and prompt updates, and re-assurance triggers.
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Why Attestra

Attestra is practitioner-led, drawing on 15+ years of GxP IT quality and validation experience across the pharmaceutical, biopharmaceutical and personal care industries. We work alongside your QA and IT teams, and we leave behind procedures they can run without us.

About Attestra

Valoryn

We are building Valoryn on the same lifecycle our consultants use, to support risk-based assurance planning, traceability and reporting for conventional and AI-enabled systems.

Valoryn is in development and testing and is not yet commercially available.

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Tell us about a new CSA program, a system change, a CSV-to-CSA transition or an AI initiative.

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