QCSFusion CAPA (Corrective and Preventive Action) Module
QCSFusion's CAPA module empowers users to seamlessly reject or approve CAPAs, monitor corrective action statuses, assign responsibilities to team members, identify trends, assess effectiveness, and effortlessly attach or link files. Throughout the entire process, the system automatically sends email alerts, keeping all members informed about the workflow status.
The flexibility of QCSFusion allows easy customization to align with your organization's unique processes and SOPs. Tailor the workflow by configuring fields with various data formats, ensuring a smooth and efficient search experience within the system.
Compliant with GMP and CFR Part 11 standards, the QCSFusion CAPA module offers a comprehensive solution, simplifying the review and approval process. QCSFusion meticulously manages the roles of authors, reviewers, and approvers, ensuring completeness and accuracy in records. With QCSFusion, you can count on the timely completion and approval of CAPAs, streamlining your quality management processes.
Features
- Interactive form attachments permit you to fill out corrective/preventive actions as the route is processed, with field locking and part 11 compliant signatures
- 21 CFR part 11 compliant
- E-signatures
- Communication via e-mail (alerts / reminders)
- Multi-level file structure so that documents can be organized effectively
- Flexible workflow that is configurable according to your already established business processes and procedures
- Detailed audit trail include
• System-stamped date and time
• User who performs the activity
• Information of action performed
• Reason for changes
- Flexible roles / responsibilities that can be assigned based on customer needs
- Searchable
- Audit Trail
- Option to stamp CAPAs for printing
- Capability to control variety of CAPA types
- Editable templates (default and / or user created)
- Ability to email a copy of CAPA to any party (auditors, customers, suppliers, etc.)
- View status of all corrective/preventive actions in your system
- Review and Approval workflow
- Cross-references to link related documents
- Attach unlimited files to any corrective/preventive action
- Task list for users to view tasks assigned to them
- Assign time requirements for certain workflows and issue alerts / reminders to assure timely completion and enforcement