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IT QA / CSV QA.

Computer System Validation audit and remediation aligned to 21 CFR Part 11 and GAMP 5. LIMS, eTMF, ERP, and similar regulated systems.

5 min read

You'll leave with: What CSV under 21 CFR Part 11 + GAMP 5 looks like in 2026 — and where Indian-CRO inspection-readiness CSV is its own niche.

/ Who this is for

The fit.

Sponsors validating systems. CROs validating their LIMS, eTMF, ERP. MedTech companies validating QMS systems.

/ The work itself

What this delivers.

CSV validation package or remediation plan aligned to 21 CFR Part 11 and GAMP 5.

/ Why this matters

Where the edge is.

LIMS-architecture specific. Cross-system pattern thinking. India-CRO inspection-readiness CSV niche — where Western firms rarely operate.

/ How engagement runs

The shape of the work.

Every engagement is scoped per situation. The shape — focused diagnostic, structured implementation, ongoing partnership — emerges from the discovery conversation rather than a fixed package. Some engagements are short and intense; some are months-long structural builds; some are recurring quality oversight. We talk first, then scope.

Discovery.

Confirm system scope and current validation state.

Scoping.

Proposal aligned to system count and audit depth.

Validation/audit.

Document review, system testing, 21 CFR Part 11 alignment.

Report.

Validation package or remediation plan.

What to do next.

If this is the work in front of you, the next step is a conversation. I read every message and respond personally. No contact forms. No sales sequence. Just a discovery conversation to understand whether the fit is real, and what the shape of the work would be.

Cadence promise: I publish weekly on regulated AI governance. If a week is missed, the journal entry explaining why goes up in real-time.

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