A finding is only resolved when its cause is understood and prevented from recurring. I help sponsors and CROs investigate audit and inspection findings, deviations and quality events to true root cause, then design CAPAs that are specific, verifiable and proportionate.
Weak CAPAs — vague actions, reflexive retraining, no effectiveness check — are themselves a common inspection finding. I help you avoid that.
What the audit covers
- Root cause analysis (5 Whys, fishbone and related tools)
- Corrective and preventive action planning
- CAPA effectiveness checks and verification
- Trending and systemic-issue identification
- Support responding to audit and inspection findings
What you receive
- Documented root cause analysis
- CAPA plan with owners, actions and due dates
- An effectiveness-verification approach
Why it matters
Regulators judge a quality system by how well it closes its own findings. Strong CAPA turns a problem into evidence that your system works.
Standards & frameworks
Frequently asked questions
What is a CAPA in clinical research?
CAPA stands for Corrective and Preventive Action — the documented process of correcting a quality problem, finding its root cause and putting preventive measures in place so it does not recur.
What makes a CAPA effective?
An effective CAPA addresses the true root cause (not just the symptom), defines specific actions with owners and dates, is proportionate to the risk, and includes a verification step to confirm the problem stays fixed.