CSV & FDA Audit Prep Consultant

I’m finalising preparations for an imminent FDA inspection and need hands-on support to close remaining gaps in our Computer System Validation package and overall audit readiness. In two to three weeks I expect to generate or polish every key document—URS, IQ, OQ, PQ, Validation Plan, RTM—then align them with risk-based assessments, CAPA tracking and fresh SOPs that withstand 21 CFR Part 11 scrutiny.

The single biggest priority is tightening the audit checklist and the supporting evidence file so an inspector can trace every requirement straight through to executed test records and approved reports without delay. I will share current drafts and raw data; your job is to rewrite, re-sequence or create missing pieces so the trail is airtight and GxP-compliant.

Systems in scope for CSV:
• LIMS
• SCADA
• ERP
• Cold & Stability Chambers with monitoring software
• RPHPLC / HPLC and other analytical instruments with software interfaces
• Purified Water and WFI monitoring software
• Electronic Document Management System (EDMS)
• Track & Trace
• e-QMS / CAPA / Deviation management

None of these platforms has a complete validation dossier yet, so you’ll start from a clean slate or overhaul fragmented material where it exists.

What I expect from you
• Author, review and finalise the full validation lifecycle documents listed above
• Perform risk assessment, derive mitigations and log CAPAs
• Draft or update SOPs to embed the validated state in daily operations
• Build a practical, inspector-ready checklist linking policies, procedures and evidence
• Advise on best practice for maintaining compliance post-inspection

You should already be fluent with FDA 21 CFR Part 11, GxP principles, EMA Annex 11, and common validation toolsets (ValGenesis, MasterControl, Kneat, or equivalent). Experience defending CSV packages during audits is essential; theory alone won’t cut it.

Success will be measured by an internally executed mock audit showing traceability from requirements to approval, zero critical gaps in CSV documentation, and SOPs ready for immediate rollout.

I’m available for quick turnaround reviews and can provide remote system access, but expect you to drive the documentation schedule proactively so we close out all items before the inspector arrives.