21 CFR 820.100(a)(5)

Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:


(5) Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems.





CAPA Implementation Phase

The CAPA Implementation phase involves executing the plan: 


  • Making planned process and quality changes
  • Keeping objective evidence of their implementation.


Documentation, as part of implementation, may include new or updated:


  • Implementation plans
  • Change management records
  • SOPs
  • Specifications
  • Training plans, etc.


The ExtraView Difference

Organizations may choose to maintain each document in its respective source system (where applicable) and a record of the change / reference to the source document in Extraview.  You may also choose to store the documents in ExtraView.  In each case, ExtraView Enterprise remains the authoritative record of change associated with the CAPA.


After implementation, there may also be a second Verification and Validation phase.


Please select the Disseminate link to move to the next CAPA phase, or select any of the puzzle pieces below to learn more about how ExtraView meets your business requirements in that specific CAPA area.  For a synopsis of Extraview’s role in the entire CAPA process, see the ExtraView CAPA Functionality Matrix.



Example Screens from Customer Implementations


  • Plan & ScheduleFollow the workflow you define, with full audit trails
  • Summary ReportingInstant summarizations, with drilldown into details
  • Alternative ViewsReport using interactive calendars to schedule implementations and monitor performance against plan
  • Assess PlansValidate plans for effectiveness before implementation
  • Integrate SOPsSOP changes and updates can be part of the process



Learn About Other CAPA Phases