CAPA MANAGEMENT

• Role-specific dashboard for senior management with clear displays of meaningful or decision-relevant information – in real time
  • Number of immediate actions, number of corrective actions, number of preventive actions
  • Breakdown according to status “open”, “in implementation”, “for effectiveness review” and number of items for each status.
  • Detailing (2nd level) per status according to priority (urgent to not relevant)
  • Visualization of the remaining duration of measures with 45-day forecast showing the status as well as overdue items
  • Drill-down to individual measures with status information (“triggering object”, “affected object”, “measure type”, responsibilities)
• Clear display of all tasks (according to selection parameter) with task attributes or properties such as risk, evaluation, workflow status and completion date
• Access to existing activities or workflow tasks
• Direct access to specific measures with a view of multi-faceted core information such as sub-measures, additional information, triggering objects (deviations, complaints, OOS, security incidents, findings, changes, etc.), affected objects (processes, assets, IT applications, machines, organizational units, products, documents, etc.) or the graphical measure life cycle with PLAN/ACTUAL comparison

• Closed and stable CAPA system with fully traceable, systematized CAPA processes
• Increased compliance level through seamless integration with other quality assurance processes
• Complete traceability and control
• Use of electronic signatures and audit trails for compliance with 21 CFR Part 11 and Annex 11
• GxP-compliant implementation including standard validation templates and methodology
• Simplified compliance with ISO 9001, 14001, 17205, 21 CFR Part 210, 211 and many others
• Easy configuration (GAMP® category 4)
• Reminders regarding initiated actions incl. escalation mechanisms
• Automated e-mail dispatch well ahead of upcoming deadlines or due dates
• Audit-proof storage of information and data
• Flexible authorization concept to ensure highest security standards
• Web-based interface for easy and worldwide access – also via mobile devices

• Intelligent client concept for mapping international group structures
• Realization of a central and group-wide CAPA management system, also across several third-party systems or several instances of systems (e.g. ERP)
• Clear management of global and site-specific action catalogs or cross-site actions
• Redundancy-free adaptation of globally specified information to local conditions
• Language packages for international use; standard scope of delivery: DE and EN
• Tools for translating the software interface into all Unicode-compatible languages
• Easy switching between languages

So-called quality anomalies, non-conformities, deviations, complaints, findings or, simply put, “errors” trigger detailed error and cause analyses, on the basis of which measures are defined, initiated and subsequently evaluated for their effectiveness. A distinction is made here between immediate measures, corrective measures and preventive measures. Corrective measures must be initiated for deviations or errors that have already occurred. Preventive measures, on the other hand, are initiated to prevent deviations before they occur. The CAPA process starts with measures to be implemented immediately in order to limit potential damage.

The regulatory requirements for corrective action and preventive action are comprehensively described, for example, in ISO 13485, Medical Device Regulation (MDR) or in 21 CFR part 820.100 of the FDA.

One of the well-known deficiencies in GMP inspections is the often inadequate documentation in the CAPA process, because “what has not been documented does not exist”. Thus, deviations are not comprehensively documented and investigated in more detail, root cause analysis is neglected and relevant CAPAs are not implemented. Similarly, no measures are taken to prevent recurring incidents, and no activities are planned to verify the effectiveness of measures. In short, the process is methodologically known and established, but allows too many degrees of freedom in analog processing and thus opens the door to errors. Numerous examples of how non- or inadequate digital CAPA processes can even lead to a warning letter from the FDA can be found under Warning Letters | FDA.

A digital CAPA solution takes into account all necessary activities and automates the entire lifecycle of the relevant processes – from the identification of the problem to the successful implementation of the problem solution. The CAPA process is thus always complete and transparent: no process or necessary activity is omitted, skipped, or forgotten; deadlines are strictly escalated in the resubmission, preventing any delay or procrastination.  Consistent down to the smallest detail, without question. But this is exactly where the strengths of digital CAPA processes based on the eQMS solution of the DHC VISION product family become apparent.

Management reports follow the top-down approach of the information pyramid. Here, the first thing of interest is an overall view of the current CAPA situation, always specific to the target group in the data aggregation. How many CAPAs are currently being processed? What is the discernible trend? Is there an increase or decrease in CAPAs and the associated number of findings, deviations, and complaints? What is the processing status of these CAPAs? Do the number of CAPAs still open predominate, or are the majority of CAPAs already being reviewed for effectiveness? Which CAPAs are overdue? Can clusters of CAPAs be identified at certain company locations? These are all highly relevant questions for quality management.