CAPA Management Software
Best Corrective Action and Preventive Action (CAPA) Management SoftwareCAPA Management Software
Benefits
Software is ideal for Pharma, It creates a paperless and automatic CAPA procedure which saves time, improves efficiency and eliminates all the manual entries. Software helps to reduce workload, improve efficiency, and provide the essential platform for companies looking to create and sustain an effective CAPA program. Software have familiar user interface so all operators can quickly learn and navigate through the applications. This helps fast, straightforward implementation and integration . It helps you plan, manage and document calibration work. Designed for all types of instruments which provides compliance for ISO 9001, FDA, GMP/ GAMP, 21 CFR Part 11.- Comprehensive User Management which covers User creation/disable, Password Policy, Group Privilages, Password Reset etc..
- Comprehensive Audit Trail which record each & every activity
- CAPA can be received from Incident/Deviation as well as we can be raised via source document e.g. – Applicable To, Details etc...
- Auto CAPA No. will generate with Target Date
- CAPA goes to reviewer for Recommended Preventive Action, Areas of Preventive Action , Impact of Preventive Action and Target Preventive Action Completion Date will allocate to relevant departments for comments
- Department Comments
- QA Manager will review the above all activity and decide about Type of CAPA (Critical, Major, Minor) along with conclusion
- QA Manager has facility to Accept or Reject the CAPA
- If QA Manager accept then facility to prepare schedule for verification
- Software has provision to generate Change Control from CAPA
- CAPA verification stage he/she will add corrective action & Preventative action on CAPA as per schedule
- CAPA Verification review stage he/she will verify the corrective action & Preventative action and ensure that CAPA will close and the final remark
- If CAPA is not completed within Target Date, Then It will be locked.
- Facility to Set Extend Target date.
- After Extension Date Review, You are able to perform activity.
- Reminders to Users provided prior a week for the CAPA which has Target Date closer.
- CAPA Trend Analysis
- Report Generate such as CAPA Report, Register, Status, Summary, Department Comments Pending, Change Control from CAPA
- Report Reflect with E-signature , Reviewer Date & Time & Reviewer Remarks.
- Software can be used via PC’s , Laptop’s and Tab’s
- Facilate to implement core functionality across sites , which helps you to achieve uniform quality practices
- We provide complete evidence of validation execution includes Installation Qualification, Operational Qualification, System Security,21 CFR Checklist , Risk Assessment, Backup Restore Validation, Disaster Recovery