Implement effective CAPAs to identify root causes, fix problems at the source, and prevent recurrence – while staying fully compliant with life sciences regulations.
Implement effective CAPAs to identify root causes, fix problems at the source, and prevent recurrence – while staying fully compliant with life sciences regulations.
In the life sciences industry, CAPA (Corrective and Preventive Action) is a core quality process required by FDA, ISO, and GxP frameworks. Whether triggered by a deviation, audit finding, complaint, or nonconformance, a well-run CAPA system helps you solve issues at the root – not just patch symptoms.
With Quality Forward’s eQMS, your CAPA process is fully digital, fully traceable, and fully connected to the rest of your quality system.
Launch CAPAs directly from audits, complaints, deviations, or safety events
Use structured methodologies like 5 Whys or Fishbone to identify real causes
Meet the requirements of FDA 21 CFR Part 820/211, ISO 13485, EU Annex 11, and GxP standards.
Trigger CAPAs from any quality event - audits, nonconformances, complaints, and more
Use built-in RCA tools like 5 Whys, Fishbone, or FMEA to guide investigations
Assign, track, and complete corrective and preventive tasks with full traceability
Every step - documented, timestamped, and audit-ready
Align with FDA, ISO, and global quality requirements - no gaps, no surprises
Ensure the issue was truly resolved before closing out the CAPA
Adapt CAPA workflows to match your quality system – no IT required
Whether you’re a small biotech or global pharma, we fit your growth stage
Designed for teams working under FDA, EMA, GxP, and ISO scrutiny
Identify recurring root causes, high-risk areas, and overdue actions
Enterprise-grade infrastructure for speed, security, and stability
Built-in 21 CFR Part 11 eSignatures, validation-ready, and always audit-ready
Open CAPAs directly from audits, deviations, complaints, or nonconformances
Use standardized RCA tools to identify true root causes
Create action plans with due dates, owners, and built-in reminders
Ensure CAPA effectiveness with follow-up tasks and documented verification
Review and formally close out CAPAs with full approval workflows
