A fixed-scope assessment of where your computer system validation stands against 21 CFR Part 11 and the FDA’s current Computer Software Assurance (CSA) expectations — ending in a board-ready gap report and a prioritized action plan.
What we assess
A focused review of the controls inspectors test and the validation model FDA now expects.
21 CFR Part 11
Electronic records and signatures — audit trails, access, e-sig integrity, controls and SOPs.
CSA maturity
How far your validation has moved from document-heavy CSV to risk-based assurance.
System inventory & risk
Your GxP systems classified by intended use and process risk.
Validation deliverables
Are your plans, protocols and reports right-sized and defensible?
Gap & exposure rating
Findings rated by inspection exposure and patient/product risk.
Prioritized roadmap
A sequenced plan: quick wins first, structural fixes scoped.
What you receive
- Part 11 controls gap analysis
- CSA maturity scorecard
- GxP system inventory & risk classification
- Findings rated by exposure
- Prioritized, sequenced remediation roadmap
- Effort estimates for each item
- Alignment to FDA CSA final guidance (Feb 2026)
- Board-ready summary report
The low-risk way to start. A defined assessment that scopes the work and quantifies exposure before any larger validation commitment.
Exposure to action plan in weeks
Scope
Agree systems and timeframe in review.
Assess
Document review, walkthroughs, control testing.
Report
Risk-rated findings and gap report.
Plan
Prioritized roadmap and next-step scoping.
Why teams choose us
Current, not 2022
Aligned to the FDA CSA final guidance finalized Sept 2025 and updated Feb 3, 2026 (QMSR-aligned) — not the superseded draft.
Fixed-fee, transparent scope
A defined deliverable and timeline — no open-ended hourly billing.
Risk-based
We focus on real exposure, not paperwork volume.
Senior consultants
Inspection-grade rigor from named practitioners.
A defined engagement with a defined price and timeline — no open-ended hourly billing. Scope scales to your systems and goals.
Get a scoped quoteKnow where you stand before your next inspection
Tell us how many systems are in scope. We’ll come back with a fixed-fee assessment plan.
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