Log the deviation
Capture quality incidents, deviations, supporting files, risk, ownership, and immediate actions.
Pharmaceutical quality
GMP CAPA Software
CAPA Manager supports pharmaceutical manufacturers, biotech companies, and life sciences organizations that need secure, auditable support for managing corrective and preventive actions in GMP environments.
- GMP workflowsSupport deviation handling, CAPA ownership, approvals, and effectiveness checks.
- Audit trailsKeep investigations, actions, files, decisions, and closure history together.
- RecordsElectronic history of changes and approval records.
Investigate and approve
Use structured CAPA workflows, RCA tools, approvals, task escalation, and controlled review records.
Maintain readiness
Track effectiveness checks, audit trails, dashboards, electronic records, and management visibility.
Pharmaceutical CAPA software for GMP quality workflows
Track, investigate, and resolve quality incidents across your operation using a purpose-built platform designed to support GMP-style CAPA environments. From deviation logging to effectiveness review, each step can be documented with audit trails, approvals, attachments, reporting, and controlled review records.
CAPA initiation
Use standardized CAPA initiation and approval processes with consistent data capture.
Root cause tools
Use built-in RCA tools including 5 Whys and Fishbone to support investigation quality.
Task escalation
Automated notifications, task ownership, and escalation workflows help actions keep moving.
Dashboards
Monitor CAPA progress, overdue tasks, effectiveness checks, and recurring issues.
GMP CAPA software for deviation and quality event management
GMP quality teams need consistent deviation handling, root-cause analysis, CAPA ownership, approval history, electronic records, and effectiveness checks. CAPA Manager can support these GMP CAPA workflows by keeping each investigation, action, file, decision, and closure record together.
CAPA Manager can support corrective action, preventive action, investigation, workflow, audit-trail, attachment, reporting, and approval processes used within quality systems aligned to ICH Q10, applicable GMP/CAPA procedures, ISO 9001:2015, ISO 13485:2016, and, where configured and procedurally controlled, FDA 21 CFR Part 11 expectations for electronic records and signatures.
Your organization remains responsible for approved procedures, validation, training, access controls, audit-trail review, record retention, electronic signature controls where applicable, certification, and compliance decisions.
- ICH Q10 - Pharmaceutical Quality System
- Applicable quality system procedures and CAPA requirements
- FDA 21 CFR Part 11 electronic record and signature expectations, where configured and procedurally controlled
- ISO 9001:2015 and ISO 13485:2016 quality management system environments
Why pharma teams choose CAPA Manager
Fast engagement
Easy-to-use interface that drives fast employee engagement.
Effective workflows
Powerful workflows that make corrective action simple and effective.
Clear visibility
Visibility across teams, departments, and global locations.
Continuous improvement
Data-driven decision-making supported by built-in analytics.
Start your free demo account today
See how CAPA Manager can help pharmaceutical operations streamline issue resolution, reduce risk, and maintain auditable CAPA records.