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.