Part 11 and CSA readiness assessment
Not sure where your Part 11 controls and CSA maturity stand? A fixed-scope review of your Part 11 controls and CSA maturity. It ends with a board-ready gap report and a prioritized action plan.
The challenges this solves
We do not know our inspection exposure
Audit trails, access and e-signature controls have not been reviewed in a while.
Our validation may be over- or under-built
We cannot tell whether plans, protocols and reports are right-sized and defensible.
Leadership wants a plan, not a list
We need findings ranked by risk, with effort estimates, before we commit budget.
What we deliver
- 21 CFR Part 11 review: audit trails, access, e-signature integrity, controls and SOPs
- CSA maturity review of the shift from document-heavy CSV to risk-based assurance
- GxP system inventory classified by intended use and process risk
- Review of validation plans, protocols and reports for right-sizing
- Findings rated by inspection exposure and patient or product risk
- Prioritized roadmap: quick wins first, structural fixes scoped
4 steps, clear deliverables
- 01
Scope
Agree the systems, records and timeframe in scope.
You receive: Agreed scope
- 02
Assess
Document review, system walkthroughs and control testing.
You receive: Part 11 controls gap analysis and CSA maturity scorecard
- 03
Report
Rate each finding by exposure and risk.
You receive: Risk-rated gap report and board-ready summary
- 04
Plan
Sequence remediation and scope the next steps.
You receive: Prioritized remediation roadmap with effort estimates
Want to know what this would take for your systems? Start with a short scoping call.
Who we do this for
- Pharma & biopharma
- Biotech
- Medical devices
- Cell & gene therapy
- CROs & clinical
Related services
Questions we hear most
What do we get at the end?
A Part 11 gap analysis, a CSA maturity scorecard and a risk-classified GxP system inventory. You also get a prioritized roadmap and a board-ready summary.
How long does it take?
The assessment moves from exposure to an action plan in weeks. The exact timeline is fixed in the scope you approve.
Is remediation included?
No. Remediation is a separate, scoped engagement. The roadmap gives you effort estimates so you can plan it.
Which guidance is the assessment aligned to?
It is aligned to 21 CFR Part 11 and the FDA CSA final guidance, updated February 3, 2026.
Know your exposure before an inspector does
Start with a fixed-fee assessment and a prioritized plan your leadership can act on.