CAPA Management
Successful businesses need to gain control over their CAPA processes to avoid regulatory sanctions and gain improvements in process performance through a streamlined and automated CAPA Management Program.
Successful businesses need to gain control over their CAPA processes to avoid regulatory sanctions and gain improvements in process performance through a streamlined and automated CAPA Management Program.
FDA inspections have found and reported significant deficiencies in CAPA processes implemented by organizations. These reports by FDA and other agencies can be seen as an indicator of quality. FDA inspectors themselves often consider these documented findings an indicator of the overall soundness of a company’s entire compliance program.
NextDocs CAPA Software Comprehensive and easy to use Corrective and Preventative Actions (CAPA) software for Continuous Improvement in Quality and Processes
The NextDocs CAPA Management software is a comprehensive solution that connects issues, investigators, and resolutions in a closed-loop module. It allows organizations to drive CAPA processes to closure using a forms-based approach that guides analysts through a series of logical steps. It manages the tracking, investigating, reviewing, approval, and closure of Corrective and Preventative Actions processes and prudently follows up with an effectiveness check for verification.
CAPAs can be automatically generated based on the analysis of deviations or audit findings, or can be created independently. The NextDocs CAPA Management Software is a comprehensive and easy to use SharePoint based software solution for businesses to gain control over their CAPA processes.
NextDocs CAPA Management Software features and benefits
| Features | Benefits |
|---|---|
| Extensively configurable electronic forms with role-based sections | Allows automation of client-defined processes and steps without customization. |
| Automatic transfer of known information (such as information from a deviation) into CAPA form | Minimizes transcription errors and eliminates wasteful manual tasks. |
| Sections locked down upon completion and subject to only compliant modifications | Improves data integrity as users cannot change data accidentally; focuses each task on the specific actions and data required for completion. |
| Dynamic routing of workflow based upon data entered | Automates the execution of defined processes, for example, including or excluding safety or regulatory input based on the nature of the CAPA; eliminates unnecessary steps. |
| Automatic assignment of tasks to predefined users, groups or roles when applicable | Ensures that tasks are handled by the appropriate users; eliminates manual tasks. |
| Automated notifications and escalations of CAPAs to the correct responsible parties | Provides participants with insight into assigned tasks and their statuses even when they are not logged into the CAPA System; highlights upcoming and overdue tasks. |
| Data-driven approach allowing capture of key information for reporting and trending | Insight into root cause, state of control and process efficiencies. |
| 21 CFR Part 11 compliant electronic signature | Allows efficient use of the system across physical locations and eliminates costs associated with printing, couriering and storing paper documents. |
| Detailed audit trail | Provides Part 11 compliance as well as insight into activities completed in the handling and closing of a CAPA. |
| Automated process forwards tasks to designated recipients upon completion of previous tasks | Increases efficiency by decreasing the manual intervention needed to process a CAPA. |
| Closed loop process | Allows automated closure (such as closure of an associated deviation upon closure of a CAPA) if all information is available to justify closure; if not, notifies responsible user to complete the closure process when appropriate. Reduces the risk of dropped handoffs and the associated compliance impact. |
| Efficient handling of supporting documentation such as photographs, emails, etc. | Allows access to supporting materials to support decision-making and investigation without controlled document processing unless appropriate. |