Pharmaceutical CAPA Software – Streamline GMP Compliance & CAPA Processes
Pharmaceutical CAPA Software for GMP & Regulatory Compliance
CAPA Manager is purpose-built for pharmaceutical manufacturers, biotech companies, and life sciences organisations needing a secure, compliant, and auditable system for managing Corrective and Preventive Actions. Designed for GMP environments, our platform ensures your CAPA process is traceable, efficient, and inspection-ready at all times.
Optimised CAPA Workflows for Pharma Quality Systems
Track, investigate, and resolve quality incidents across your operation using a purpose-built platform designed for GMP environments. From deviation logging to effectiveness review, every step is documented with full audit trails and electronic signature support.
- Standardized CAPA initiation and approval processes
- Automated notifications and task escalations
- Built-in RCA tools: 5 Whys, Fishbone
- Risk-based classification of CAPAs based on severity and impact
- Real-time dashboard to monitor CAPA progress and overdue tasks
- Electronic records
- Embedded digital signatures linked to CAPA data
- Supports continuous improvement and audit readiness
Regulatory compliance made easy
CAPA Manager supports key pharmaceutical regulatory standards and keeps you audit-ready with secure electronic records, and embedded digital signatures for complete traceability:
- ICH Q10 – Pharmaceutical Quality System
- EU MDR and IVDR requirements
- ISO 13485:2016 and ISO 9001:2015
Learn more about CAPA Manager and how it helps you build a connected, compliant, and efficient quality system. From deviation logging to CAPA closure, your teams are empowered to take decisive, documented action — all in one centralised system.
Why pharma teams choose CAPA Manager
- Easy-to-use interface that drives fast employee engagement
- Powerful workflows that make corrective action simple and effective
- Clear visibility across teams, departments, and global locations
- Data-driven decision-making supported by built-in analytics
- Fosters a culture of proactive quality and continuous improvement
CAPA Manager vs Manual CAPA Process
| Feature | Manual Process | CAPA Manager |
|---|---|---|
| CAPA Initiation | Paper forms or static Word/Excel templates | Automated forms with validation & role-based access |
| Root Cause Analysis | Manually compiled and inconsistent | Built-in 5 Whys, Fishbone tools |
| Task Management | Email chains and manual follow-ups | Workflow-driven with automated assignments and escalations |
| Audit Trails | Disparate logs, difficult to trace | Complete, tamper-proof audit trail for every action |
| Compliance | High risk of missed steps or incomplete records | Fully traceable, and compliant digital records |
| Reporting & KPIs | Manual spreadsheet tracking | Real-time dashboard and trend analysis |
| Effectiveness Checks | Often overlooked or inconsistently documented | Built-in lifecycle steps with reminders |
Start your free demo account today
See how CAPA Manager can help your pharmaceutical operations streamline issue resolution, reduce risk, and stay compliant.