Analyze

21 CFR 820.100(a)(7)

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

 

(7) Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.

 

 

 



  

CAPA Management Review Phase

The Management Review phase, like the Dissemination phase of CAPA, spans the process end to end. This addresses the requirement that senior levels of management provide CAPA oversight, sign-off on risk severity and action plans, and routinely monitor progress against plan, as well as effectiveness metrics and outcomes.

 

The ExtraView Difference

 

ExtraView Enterprise serves as the central repository for both product and process data sources of issues.  The platform allows you to have a single source of the truth.  It transparently supplies evidence on demand, that all issues / problems were identified, triaged, and analyzed for risk by the appropriate stakeholders. ExtraView Enterprise manages the workflow around issue analysis as well as tracking the active decision and rationale of whether or not to generate a CAPA.

 

ExtraView Enterprise tracks and supports the workflow steps associated with your Management Review process, including sign-off by each responsible individual at appropriate phases in the process.

 

ExtraView's workflow capabilities permit the introduction of control points, preventing forward movement or closeout until all conditions have been met (e.g. everyone has signed off). Through our robust reporting tools, you can easily monitor progress against plans as well as any regulatory deviations, as required by the management team.

 

Most importantly, ExtraView Enterprise will maintain the objective evidence that management is actively overseeing the CAPA process.

 

 

Example Screens from Customer Implementations

 

  • Variety of ReportsEasily create, publish and share reports and charts
  • Review Summary or DetailManagement can drill down into the detail at any time
  • Review and Compare PerformanceExtensive reporting without the need for IT involvement
  • DashboardsReadily share information with all stakeholders
  • Robust ReportingEasily create summarizations for review, drill down into details

 

Learn About Other CAPA Phases

 

Please select the Document link to move to the final CAPA phase. 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.