CAPA Procedure - Corrective Action Process

MasterControl's CAPA Procedure - Corrective Action Process Systems are designed by industry practitioner for automating the CAPA process in any organization. A CAPA system is the crux of any quality and compliance process. It is a regulatory requirement that FDA / global regulatory inspectors and ISO auditors consider critical. An automated CAPA system reduces audit time and findings, and a decreases risk of product recalls. It improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.


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Educational Materials

Get insider information about the most relevant issues in CAPA Processes today, and how to navigate and overcome the complexities of FDA Regulations.

Product Data Sheets
White Papers
  • Learn how to identify, correct and prevent problems that plague weak CAPA systems as well a seven distinct procedures that can insure compliance with FDA and ISO requirements.
  • Learn why the FDA, ISO and other regulatory agencies place so much emphasis on CAPA and closely scrutinize the amount of open CAPAs an organization has. Also examine the pros and pitfalls of three different approaches to CAPA management.
  • Medical device manufacturers are seeing increased warning letters, resulting in supply chain delays and even plant closures. CAPA guru Ken Peterson shows you how to kick-start your CAPA process and keep the FDA off the radar screen.
Product Data Sheets
Webinars
  • Learn the number one item cited by the FDA in 483s and warning letters. And why poor investigation techniques only identify superficial symptoms rather than root cases.

Product Information

Discover how MasterControl CAPA Software can manage your CAPA process, all while mitigating risk, improving speed-to-market, and generating ROI.

Product Data Sheets
Product Data Sheets
  • Avoid 'death by CAPA' and learn about how MasterControl CAPA software automates, streamlines and manages not only all CAPA-related documentation and activities, but also the documents and tasks of other quality processes.
  • In this FDA-approved workshop you will learn root cause analysis (RCA), risk based issue review and quality event management (QEM) methodologies, which are critical when implementing CAPAs.
Product Data Sheets
Q&A's
  • Learn from QMS/CAPA guru Ken Peterson about how good event management is essential to a reliable QMS that can withstand the toughest regulatory scrutiny.

Toolkits & Demos

Get in-depth, comprehensive resources to guide development of your CAPA program.

Product Data Sheets
Interactive and Live Demonstrations
  • The MasterControl quality management system (QMS) delivers a wide range of software solutions for quality management, document control, product lifecycle management, supplier management, audit management, training management, and more based on your business needs. This overview demonstration shows how MasterControl's QMS eliminates waste, simplifies audits, and facilitates compliance with regulatory guidelines.
Product Data Sheets
Toolkits
  • Tailored specifically for Quality Managers. Find out how closed-loop quality management can help you connect people, processes, and data across the value chain. Includes: 4 webinars, 3 white papers and much more.


Corrective Action Process and CAPA Procedures


CAPA (Corrective Action / Preventive Action) is often used synonymously with 'corrective action procedure'. A CAPA -- the overall effort to investigate and correct quality issues to prevent recurrence -- is the lynchpin of any quality system. It is a regulatory requirement that both FDA inspectors and ISO auditors consider singularly critical. When implemented properly, a corrective action procedure improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.


Steps in a Corrective Action Process


A corrective action process is not reworking or remaking an item to bring it back into specification. Patching up a mistake doesn't address what made it happen in the first place and it won't prevent a recurrence.

A CAPA procedure can be documented using either a paper or electronic system. Either way, the process is basically the same:

  • Document that was specified versus one that was found. Check the functional specifications and any other requirements against the actual result.
  • Determine how much time should be allowed for a corrective action process (or CAPA response).
  • Decide who will investigate the problem, find a solution and perform the corrective action procedure.
  • Research and document the cause of the problem.
  • Plan how to keep the problem from recurring.
  • Communicate the corrective action process to everyone involved, at each appropriate level.
  • Periodically check to ensure the problem is solved and that the corrective action procedure was effective.

Automating the above steps greatly facilitates the completion of the CAPA process.



How Can MasterControl's CAPA Process & Procedure Help?


MasterControl CAPA automates routing, notification, delivery, escalation and approval of CAPAs and all related documentation. It automates management of entire corrective action procedures, while providing a secure, centralized, and web-based repository for all CAPA documents.

For More Information on Document Control Software Systems

For additional details about the Document Control Software Systems from MasterControl, please feel free to contact a MasterControl representative.