Deviation and CAPA Software
Deviations and corrective and preventive measures (CAPA) are among the most important, practical and key concepts of quality assurance in the pharmaceutical industry. Deviation refers to the difference between expected or normal values and observed values for a product or process. These deviations can occur during testing, sampling, manufacturing or acceptance of raw materials and finished products. The process of dealing with deviations includes identifying their criticality, performing root cause analysis and proposing corrective and preventive measures. FDA guidelines emphasize documenting procedures for stopping operations, recording nonconformances, investigating discrepancies, and implementing corrective actions. The general concept of deviations is any difference between instructions, processes and rules and conditions defined by high-level documents in production and non-production space. The quality assurance department is required to collect these events from the reporters and detect possible deviations during the implementation of a predefined process, and if the deviation is significant, corrective and preventive measures must be taken by implementing the CAPA process to achieve follow up on results and effectiveness.
1. Register Deviations
2. Manager Approval
3. QA Specialist Review
4. QA Manager Approval
5. Register CAPA
6. CAPA Reports
7. Close Case
Delete Deviation Case
According to data retention standards and the record of registered events for deviations and CAPA, no data will be absolutely deleted by users from the deviation automation system. In fact, if a user deletes a case (provided they have the required access level), the registered data will still be traceable and viewable in a separate category. In reality, after deletion, the case will be moved from the main and active deviation box to the deleted box, and it cannot be edited or its status changed, but the entire case can still be restored if necessary. According to Track and Trace principles, all registered cases and activities, edits on the case, deletions, or restorations are recorded as an event and are traceable and reportable.
Print Deviation Case
All processes related to deviations and CAPA are fully mechanized and designed without the need for printing or paper forms. However, according to existing needs, users can, if necessary, obtain a printed or PDF output version of the case with all registered data after the fourth stage of the process (QA Manager Approval) and classification of the case. Moreover, if the process continues and CAPA is registered, at the end of the seventh stage (case closure), it is possible to print or obtain a PDF output of the entire event case.
