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CSA: put the thinkingwhere the risk is.

The FDA's CSA guidance moves effort from documentation to critical thinking. Merivane does the scripted testing for high-risk functions and gives your team the time to think about what matters.

Book a demoWhere it sits in the chain
Where critical thinking enters the chain
  1. Approved requirement
  2. Test scripts
  3. Autonomous execution
  4. You take over
  5. Defects logged
  6. Signed OQ / PQ report
Risk

Risk level first. Test depth follows.

The agent proposes a risk level for each function, based on impact to patient safety, product quality, and data integrity. You decide the level. The rationale is recorded.

  • You decide, not the agentRisk levels are proposed. Approval is yours.
  • Rationale recordedEach proposed level carries a one-line reason.
  • Approved levels are signedApproval is a signed event under Part 11.
Risk-based test approach3 of 12 functions
FunctionImpactLevelApproach
Approve batch recordPatient safetyHighScripted
Print certificateData integrityMediumUnscripted, with objectives
Change dashboard themeNoneLowAd hoc

Rationale: approve batch record appears in every batch and carries the highest patient-safety impact.

Testing

Scripted where it must be. Unscripted where it should be.

High-risk functions run a scripted test. Lower-risk functions run an exploratory session with an objective and a time box. Both are captured as evidence.

  • Same evidence standardExploratory sessions are captured with the same hashes as scripted steps.
  • Findings become defectsA finding in an exploratory session opens a defect record.
  • Both in the reportThe report shows scripted and unscripted results together.
Print certificate · Medium riskTwo approaches, one function
Scripted
StepExpected result
1Certificate opens as PDF
2Batch ID matches record
Unscripted
ObjectiveCheck certificate output for edge cases
Time box30 min
TesterPriya N.
Findings3
Screenshots7, hashed
Documentation

Less paper. Same assurance.

CSA does not remove evidence. It puts full evidence where the risk is high, and less where it is low. The chain stays the same.

  • Evidence follows riskFull evidence where risk is high, less where risk is low.
  • The chain does not changeOnly the risk levels you approve change between CSV and CSA.
  • Documentation supports the decisionPaper records what you decided, not every click.
Traditional CSV vs CSAPer function tested
Screenshot every step→Evidence where risk needs it
Script every function→Script high risk
Document to prove→Document to decide

Read: From traditional CSV to CSA

Where this fits

Read more, or see the chain end to end.

InsightsFrom traditional CSV to CSAWhy the FDA's guidance moves effort from paper to critical thinking.Use caseComputer system validationIQ, OQ, and PQ for a browser-based GxP system, end to end.PlatformTest script generationFrom an approved requirement to scripts you can approve.

Questions about CSA.

If your question is not here, ask us. We reply within one working day.

Is CSA accepted outside the US?

CSA is FDA guidance. The risk-based approach matches GAMP 5 second edition, which EU inspectors know.

Does CSA mean less evidence?

Less evidence where the risk is low. Full evidence where it is high.

What differs between CSV and CSA in Merivane?

The risk levels you approve. The chain is the same.

Does the agent do unscripted testing?

No. People do. The agent captures the session.

Now onboarding validation pilot partners

See a full run on one of your systems.

Bring one approved requirement. We show you the chain end to end, on a system you already use, in under an hour.

Book a demo
Reply timeOne working day
FormatLive run, 45 minutes