CAPA SOFTWARE

• Can the names used be changed?

In workflow administration, you can configure the names of the process steps, field names and value sets.

• Can the specified steps be changed?

The CAPA process flow is structured in accordance with GxP regulations and has been created in consultation with QM experts. Against the background of the validation documentation, the process steps are therefore mandatory. However, each process step contains a “custom panel” that can be used to display further information or initiate actions.

• Is the content of all process steps visible?

When editing a process step, only that step can be edited, but the other process steps are visible.

• Are there time limits for editing the process steps?

Time limits can be entered for each process step in the administration area. Reminder messages are sent before the process steps are due. The reminder message is sent to the person processing the task, the coordinator and the configured group that is to be informed about the reminder (e.g. QA). A reminder is sent with the configured subject line.

• Is it possible to evaluate CAPAs?

The essential data of a CAPA is transferred to the attributes of the data record. You can use this to search for and create evaluations of the CAPAs that have been created. You can optionally export the evaluations as PDF, EXCEL or WORD documents.

• Are there templates for measures in a CAPA?

After a measure has been entered, it can be saved as a template in the measure table. The templates are available for insertion into a CAPA. The date for the measure is calculated based on the duration entered in the template.

• Can tasks be delegated?

In all process steps following initiation, you can forward the process step to another person. The recipient’s authorisation is checked during selection.

• Can process steps be corrected retrospectively?

In principle, a process step is completed with an electronic signature and can no longer be corrected. The “Step back” function can be used to return the process to a previous process step. The user who completed this step receives it again for processing and the process continues from this step. Each return to a previous step is recorded in the audit trail.

• Can a process be cancelled?

It can be configured so that the process can be cancelled at any process step. To cancel, a reason must be entered in a mandatory field. Only the process coordinator can cancel the process.

• Can attachments be stored for a CAPA?

If additional files are required for a process, attachments can be uploaded in all process steps and linked to the current process. The attachments are stored under a corresponding document type in the DMS and can be viewed by all process participants in CAPA under “Attachments”. You can configure which file types can be saved as attachments and how large the files may be.

• What is CAPA and why is it important in quality management?

CAPA stands for Corrective and Preventive Actions. This process is a central component of the quality management system (QMS) and serves to identify and remedy problems as well as prevent future incidents.

Corrective actions aim to analyse existing problems or deviations and implement permanent solutions to prevent them from recurring. Preventive actions, on the other hand, deal with identifying potential problems and introducing measures to prevent them from occurring in the first place.

The importance of CAPA lies in its ability to promote the continuous improvement of a company’s processes and products. Through the systematic recording, analysis and correction of errors, as well as the prevention of potential risks, CAPA contributes significantly to increasing product quality, compliance with regulatory requirements and customer satisfaction.

• How is the CAPA process implemented in practice?

The implementation of the CAPA process usually follows several standardised steps that ensure the systematic and effective handling of corrective and preventive actions:

1. Problem identification
   Deviations: Identification of problems such as production errors, complaints or internal audit results that indicate a deviation from the specified processes.
   Non-conformities: Identification of discrepancies with regard to regulatory requirements, such as EU GMP guidelines, and internal quality standards.
2. Root cause analysis
   Investigation: Systematic analysis to determine the root cause of the problem.
   Data analysis: Analysis of process and production data to identify patterns that contribute to identifying the causes.
3. Corrective actions
   Development of measures: Based on the root cause analysis, concrete steps are developed to remedy the problems. This may include adjustments to work instructions, technical specifications or production processes.
   Implementation: The measures developed are integrated into the affected processes. If necessary, adjustments to the software or production layout may be required.
4. Preventive actions
   Risk assessment: After the problem has been resolved, a thorough assessment is carried out to determine whether similar problems could occur in other areas or processes.
   Preventive measures: Preventive measures are implemented to prevent the problem from recurring. These include staff training, improvements in process monitoring and adjustments in the area of quality control.
5. Effectiveness testing
   Verification: Once the corrective and preventive measures have been implemented, a review is carried out to ensure that the measures are effective and that the problem has been solved in the long term.
   Long-term monitoring: Continuous monitoring of processes and results ensures that the preventive measures are successful and that no further deviations occur.
6. Documentation and reporting
   Logging: All steps of the CAPA process – from problem identification to effectiveness testing – are comprehensively documented. This is essential for demonstrating compliance with regulatory requirements.
   Audit trail: A digital CAPA system provides a complete audit trail, proving that each measure has been properly implemented and documented.
7. Continuous improvement
   The CAPA process is cyclical and promotes continuous improvement of the quality management system (QMS). The insights gained are incorporated into strategic planning and process optimisation.

Through this systematic approach, the CAPA process ensures that problems are not only resolved in the short term, but also that future risks are minimised.