CAPA Management

Karan Shinde
March 20, 2021


CAPA is the term used for two separate documentations "Corrective Actions" and "Preventive Actions, commonly documented as Corrective and Preventive Actions.

The purpose of the corrective and preventive action subsystem is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence

CAPA is the mandatory regulatory requirement in almost every Quality management system like ISO9001, Med-tech quality management ISO13485, Aerospace Quality Standard AS9100D and Other FDA and ISO Certifications.

Identify the issue, Evaluate the problem, Investigate the failure, Analyse the root cause, Plan the resolution, Implement the plan and Follow-up are the 7-steps that should be undertaken in CAPA Process.


Challenge:

  • Organisations manage CAPA manually using Microsoft Word or Excel or other similar applications, there is no centralised system or process. They usually rely on Free ISO Templates available on various websites.
  • There no visibility of updated records and report, result in a Complex and Poorly executed process
  • Lack of cross-functional involvement due to unavailability of collaboration in the system


Solution:

  • ‚ÄćOrganisations can Build a CAPA Management App with the Officexlr Low-code platform to manage their Corrective and Preventive actions in one place.
  • Prepare and configure the forms for the Issue with Problem and Action, Link Users to Assign one of them as an Investigator.
  • Officexlr allows users to collaborate, with using this feature organisations can ask their Investigators to Identify and Report the root cause.
  • Approval workflow for multilevel approval and authorization hierarchy can be configured, so managers can review CAPA Created by their teams, Follow-up on the same till Resolution.
  • You can also, connect Communication tools like Slack, Microsoft Teams, or Gmail via Zapier, to notify internal teams and employees on Issue or Problem creation.
  • Organisations can build their Reports with Officexlr's Powerful Report builder to track revision history and audit log for document share report.


Benefits:

  • Digital QMS can help organisations to streamline and automate the CAPA processes.
  • ‚ÄćEliminate manual document management and Save 50% time on CAPA Management and Quality compliance.
  • Get data visibility, no need to search spreadsheets and emails.
  • Improved Transparency, Data Security and productivity.
  • Reduce Administration and Management time and efforts.
  • Avoid Profitability loss caused due to downtime, repetitive problems and issues.

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