A well-functioning CAPA (Corrective and Preventive Actions) process is critical in order to ensure quality and efficiency in developing and operating processes.

Failure to establish and maintain procedures for implementing corrective and preventive action is an appalling yet common warning from the FDA to companies. It is vital that your CAPA system are able to minimize risk and prevent problems; otherwise it will pay during a regulatory inspection if not before.   

The question you should be confident in answering is: What the quality status of your CAPA system? Does it measure up to FDA requirements? Does it improve and streamline operating processes and change management?

CAPA Management with Platina QMS

Electronic CAPA management is a part of Platina QMS solution allowing flexible management of activities related to quality and change management. From initiation to validation and acceptance our Platina QMS software solution enables excellent documentation of all steps including; investigation, testing, review, approval and closure cycles.

Platina QMS creates a complete transparency in the quality work. It provides managers real-time visibility into the critical processes. Furthermore, it allows for all employees to actively participate in the quality work through easy-to-use and pre-defined forms that initiates a CAPA process. The integrated QMS system also provides seamless traceability to related processes, e.g. Change Control and Training.

Benefits using Platina QMS for CAPA

Some of the benefits using Platina QMS for CAPA Management is:

  • Reduction of lead times through automated stages in the CAPA process
  • Reports are easily accessed in real-time for faster analysis and closure of open CAPA cases
  • Saves both time and cost of regulatory compliance through electronic signatures and audit trails.
  • Facilitates compliance with 21 CFR Part 11, EU Annex 11
  • Provides pre-defined and configurable CAPA process workflows
  • Seamless integration and traceability to related quality processes