Validation runs itself.You stay in control.

Give Merivane one approved requirement. It writes the test scripts, runs them on your GxP system, logs the defects, and assembles the OQ or PQ report. You review each step, take over when you choose, and sign.

Book a demo See how it works

21 CFR Part 11E-signatures and records

EU Annex 11Computerised systems

GAMP 5 · CSARisk-based testing

One chain, end to end. It pauses where you want to act, then continues.

One chain from approved requirement to signed report. You decide where to step in.

Most tools cover one or two links of this chain. Merivane runs all six. Every link is reviewable, and every one can be taken over by your team.

Step 1 of 3

It writes the test scripts

Upload an approved URS, FRS, or change request as PDF or Word. Merivane parses the requirements, proposes a risk level for each, and writes scripts with every step, expected result, and acceptance criterion. Edit any step. Approve to lock.

You approve the risk levels and the scripts

URS-014 · Batch record approval12 scripts · 96 steps

Step	Action	Expected result
1	Log in as QA-02	Dashboard opens, role shows QA	High risk
2	Open batch record BR-2219	Record opens in review state	High risk
3	Enter sample result 4.2 mg	Value saved, audit entry created	Medium
4	Approve record	Status changes to Approved	High risk
5	Verify audit entry	Entry lists user, time, meaning	High risk

Step 2 of 3

It runs them on your system

The agent drives your configured LIMS, QMS, or MES in a test account, step by step. Each step passes or fails with a hashed, time-stamped screenshot. When it is unsure, it stops and hands you the controls.

You watch, and take over any time

OQ-2214 · Step 4 of 96LIMS-UAT · QA-02

AutoManual

lims-uat.internal/records/BR-2219

Batch record BR-2219 · Line 4In review

Sample result: 4.2 mg

Reviewer comment

Reviewed by QA-02Approve record

Screenshot capturedsha-256 · 14:32:07 UTC · locked

Evidence

Step 3 of 3

It logs the defects and traces every step

Failed steps become locked defect records, linked to the step, assigned, and tracked to closure. Every executed step is traced to its requirement and to hash-anchored evidence. Manual takeovers are attributed to the person who acted.

You manage defects and close them

OQ-2214 · DefectsTraceability 14 of 14

DEF-031 · Print certificateStep 6 · Expected PDF download · Seen: blank tab

Open · Vendor

Linked evidence2 screenshots · sha-256 · 14:41:52 UTC

Locked

TraceURS-014 → TS-014-06 → Step 6 → DEF-031

Complete

Impact assessmentNo impact on requirement acceptance · Priya N.

Recorded

When the AI is unsure, it stops and asks you.

Screens change. Dialogs appear. Sessions expire. Instead of guessing, the agent pauses, tells you what it expected and what it saw, and hands you the controls.

Your manual actions are captured as evidence with the same time stamps and hashes, attributed to you.
Hand control back and the run continues from the next step.
Every handover is recorded in the audit trail.

Step 4 needs youExpected the approval confirmation. Seen: a session time-out warning. Take over, or skip this step and continue.

Take overSkip step

Priya N. completed step 42 screenshots captured · returned control at 14:33:10 UTC

The output

The validation package that writes itself.

The OQ or PQ report assembles itself from the run: test summary, defect log, and traceability matrix. Manual steps carry the name of the person who performed them. You sign under 21 CFR Part 11. The package is exportable and audit-ready.

Full traceabilityEvery requirement traced to executed steps and hash-anchored evidence.
AttributableAI steps and human steps are labelled. Nothing is blended.
Signed, not just savedIdentity, meaning, and time bound to the signature.

OQ-2214 · Operational Qualification reportRev A · Page 1 of 42

Batch record approval workflowSystem: LIMS-UAT · Requirement: URS-014 · Generated by Merivane

1.0 Purpose

To verify that the batch record approval workflow operates according to URS-014 in the configured LIMS environment.

2.0 Test summary

Step	Action	Performed by	Result
1	Log in as QA-02	Merivane	Pass
2	Open batch record BR-2219	Merivane	Pass
3	Enter sample result	Merivane	Pass
4	Approve record (manual takeover)	Priya N. (QA)	Pass
5	Verify audit entry	Merivane	Pass
6	Print certificate	Merivane	Fail · DEF-031

3.0 Defects

1 defect logged and locked. DEF-031 linked to step 6, assigned to vendor, open. No impact on requirement acceptance.

4.0 Traceability

14 of 14 requirements traced to executed steps and hash-anchored evidence.

Reviewed and approvedPriya N. · QA Lead · 2026-09-12 14:32 UTC

Signature meaningApproved · 21 CFR Part 11
Identity verified by SSO
Hash 9f3c…a71e

Assembled by Merivane

OQ-2214 · Rev A · Confidential

The same validation. Days, not months.

Execution and documentation are where the months go. Those are the parts Merivane does for you. The evidence is the same.

By hand

Scripts, clicks, screenshots, matrix, report

Months

With Merivane

Review, take over, sign

Days

Based on a 14-requirement OQ with 96 test steps on one system. Your numbers will vary.

The controls an auditor expects, built in from the start.

Compliance determination stays with your quality organisation. We supply the technical controls and the documentation to support your assessment.

Audit trail

Tamper-evident by design

Append-only, hash-chained entries. Any later change is detectable.

21 CFR Part 11

Attributable e-signatures

Each approval is bound to identity, action, meaning, and time.

Access

Role-based, SSO only

Fixed roles per system, including a read-only auditor role.

Evidence

ALCOA+ capture

Captured at execution time, verified against live system state, hash-anchored.

For teams that own the validation, on the systems they already run.

Whether you validate for clients or for your own systems, the chain is the same.

Contract research organisationsRun more client validations with the same team.
Small and mid-sized pharmaValidate without a large CSV department.
Part 11 programmesElectronic records and signatures, done correctly.

Systems in scope

Any browser-based GxP system you can give a test account to.

LIMSQMSMESERPEDCeDMSeTMFCTMS

From the blogWhite paper · PDF

Efficient UAT for GxP Systems: Where Merivane.ai Helps

Regulators ask for confidence proportionate to risk, not a volume of paperwork. Our white paper sets out a risk-based UAT model for Part 11 and Annex 11, and where AI cuts effort without cutting assurance.

4 min readRead the article

Trust and securityHosting, data residency, access control, and evidence integrity in detail.

Clear answers for regulated teams.

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

Does Merivane replace my QA or CSV team?

No. It does the repetitive execution and documentation. Your team reviews, approves, takes over when needed, and signs. Compliance determination stays with your quality organisation.

What systems can Merivane validate?

Any browser-based GxP system you can configure a test account for: LIMS, QMS, MES, ERP, EDC, and document management systems.

What happens when the AI gets stuck?

It stops, explains what it expected and what it saw, and hands you the controls. Your actions are captured as evidence with the same time stamps and hashes.

How is this different from a validation document tool?

Document tools organise files you produce. Merivane produces them: scripts, execution evidence, defect records, and the final OQ and PQ reports.

Where does my data live?

In a single-tenant environment in the region you choose. Evidence is hash-anchored and exportable at any time.

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