Audit and validation readiness
Prepare your systems and evidence before the review.
We audit individual systems, run health and process checks, and bring validation records, change documentation and quality processes into order. We identify gaps and close them before an inspection, audit or major system release.
Readiness review
- EVIDENCE · GAPS · ACTIONS
- 1
Inventory
Validated systems, owners and current status
- 2
Evidence check
Validation records, change control, traceability
- 3
Gap list
Missing or outdated evidence, ranked by risk
- 4
Remediation
Close gaps and prepare teams before the review
- What we deliver
From system audits to inspection-ready.
- Audit
Individual system audits
Audit of a single system for configuration, access, data integrity, validation status and compliance with 21 CFR Part 11 and EU Annex 11.
- Check
Health and process checks
Review of how systems and processes work in practice, against SOPs and the validated state, with clear findings and actions.
- 01 · Review
Evidence review
Validation documentation, traceability, change records and periodic reviews for each system.
- 02 · Assess
Gap assessment
Missing or outdated evidence, ranked by risk, with owners agreed for each action.
- 03 · Remediate
Remediation support
Update protocols, reports, SOPs and traceability, and execute any validation still needed.
- 04 · Prepare
Readiness support
Prepare teams and records, and support during the audit or inspection.
- Typical triggers
When teams call us.
- FDA or customer audit announced
- Major serialization or ERP release
- New system going live
- Periodic review overdue
- Findings from a previous audit
- Change of validation approach to CSA