Corrective Action (CAPA) Software

Corrective Action (CAPA) Software

An effective CAPA system ensure compliance to quality standards. The isoTracker CAPA capabilities are included as a standard feature with the Complaints Management, Audit Management, Training and Non-Conformance modules.

 

Using isoTracker CAPA software, you can:

  • Record non-conformances
  • Identify and record root causes
  • Investigate the most effective corrective measures
  • Record the corrective actions required, the actions taken and their effectiveness
  • Ensure corrective actions are properly implemented and closed

While the isoTracker CAPA module is not a stand-alone application it integrates fully with the Complaints, Audits, Training and Non-Conformance modules and is used to correct issues identified in those modules.

Why is CAPA important?

Jargons such as “we must be compliant” is an easy but not very effective way to justify the use of a CAPA systems. Probably, a more complete justification would be “we need to eliminate causes of problems”.

In fact, a CAPA system should not be viewed as the required outcome of a deviation or event. It should instead be treated as a process that starts with the identification, evaluation, and investigation of a problem, and moves on to determining the best method of resolution, implementing that resolution and checking on its effectiveness. Finally, it ends with its closure.

With the outcome being that:

  • Quality issues are resolved
  • Customer issues are reduced
  • Regulatory requirements are met
  • Improvements identified and implemented
  • Consistent approach across the organization

 

Investigate

  • Assign time-based investigative tasks to individuals or teams
  • Facilitate the identification of Non-Conformances
  • Supports Root Cause analysis
  • Trigger reminders and escalate when replies are outstanding

Record Non-Conformance

  • Record comprehensive data on Non-Conformances
  • Include non-conforming audit items when login from the Audits module
  • Include failed test questions or survey questions when login from the Training module
  • Ability to re-use previous Non-Conformances
  • Link to one or more Root Causes

Record Root Causes

  • Record the results of the Root Cause analysis
  • Link to one or more Non-Conformances

Corrective and Preventive Action

  • Investigate the corrective measures
  • Identify the Corrective Action required and assign responsibility
  • Track implementation of the Corrective Action plan which may include a task in another module
  • Check for effectiveness and when satisfied with the results close the Corrective Action plan
  • Follow a similar process for Preventive Actions

Reporting and Metrics

  • Provides comprehensive data into non-conformance and CAPA data
  • Follow trends on a modular or business basis

Encourage collaboration

  • Accelerate Non-Conformance investigations, Root Cause analysis, as well as CAPA management through automated tasks workflows
  • Enhance teamwork on Non-Conformance, Root Cause and CAPA processes across the organization and keep projects on track with automated alerts and notifications

Consistent process

  • Reduce repeat Non-Conformances through cross module analysis processes
  • Ensure that quality issues are resolved consistently
  • Ensure that stakeholder issues are also resolved consistently
  • Provide a comprehensive view of non-conformance and CAPA activities to make sure that nothing slips through the cracks

Improve processes

  • Lower the cost of poor quality
  • Strengthen compliance with quality standards and regulations

with a 60-day free trial

Our clients say

"...important to maintain tight control over policies in a dynamic and intense clinical environment... becomes simple when documents are managed by reliable, very easy-to-use and well supported software, such as isoTracker."

Flax Bourton Public Mortuary, Bristol, UK