Key Features:

  • It manages the complete flow from initiating deviation, conducting investigation, root cause analyses and generating CAPA if required, till closure.
  • Planned and unplanned deviations can be managed.
  • Architecture allows application access using web technology.
  • Electronic Signatures and audit trails as per 21 CFR Part 11 guidelines of USFDA.
  • Primary and secondary investigation can be carried out during the deviation work flow depending on Site QA requirement.
  • Root cause analysis, Impact assessment categorization based on which MIS reports can be generated.
  • Auto task reminders through emails and notifications based on target dates given for action points and other activities like review/approve/impact analysis.
  • Deviation can be monitored and tracked by Site QA using different tracking options.

Deviation Flowchart: