Key Features:

  • It manages the complete flow from initiation of CCP to closure after effective review.
  • It is linked to other QMS modules like DMS(DocsExecutive) and eTraining.
  • Architecture allows application access using web technology.
  • Electronic Signatures and audit trails as per 21 CFR Part 11 guidelines of USFDA.
  • Default impacted departments can be loaded as per product type or category, so user need not remember everytime when adding impacted departments.
  • Each HOD from impacted departments can add action points as per CCP requirements with target dates.
  • Auto task reminders through emails and notifications based on target dates given for action points and other activities like review/approve/impact analysis.
  • CCP can be monitored OR tracked by Site QA using different tracking options.
  • MIS – Department and Locationwise Trend analysis report

CCP Flowchart:

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