Key Features:

  • It manages the complete flow from initiation of CAPA till closure after effective review.
  • Architecture allows application access using web technology .
  • Electronic Signatures and audit trails as per 21 CFR Part 11 guidelines of USFDA.
  • Standard questionnaire can be configured which is to be answered by concerned departments during the CAPA flow.
  • Impacted departments can add Corrective and Preventive actions as suggested by Initiating department and Site QA.
  • To verify effectiveness of CAPA each action can be assigned to different reviewers. Input of effectiveness check is recorded.
  • Auto task reminders through emails and notifications based on target dates given for action points and other activities like review/approve/impact analysis.
  • CAPA can be monitored and tracked by Site QA using different tracking options.

CAPA Flowchart:

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