Expertise
CAPA, Deviations & Remediation
Repeat findings are usually a symptom of an investigation system that closes records rather than solves problems. We help organizations investigate properly, choose corrective actions that address the actual cause, and prove effectiveness afterward.
What we do
- Deviation and nonconformance system design, triage and risk classification
- Root cause analysis methodology, training and facilitation of complex investigations
- CAPA system design, prioritization and effectiveness verification
- Backlog reduction programs for overdue investigations and CAPAs
- Complaint handling and MDR/adverse event system interfaces
- Quality remediation program management with milestones and governance
- Independent review of investigations for adequacy and defensibility
Common failure patterns
Investigations that conclude with human error and retraining. Corrective actions written as a new procedure for a problem the existing procedure already addressed. Effectiveness checks that verify the action was completed rather than that the problem stopped recurring.
We work with investigators and quality reviewers directly, on live records, until the standard is understood and repeatable inside your organization.
Start a project
Tell us what you're working on.
Describe the product, the process or the problem. We will tell you honestly whether we are the right people to help, and who should be on the team if we are.