Pharmaceutical, Medical Device, and BioTech companies are
required to detect and react to non-conformances and ensure that
appropriate actions are taken to correct and prevent future
occurrences. Still, more than half of the FDA Form 483
observations and warning letters cite Corrective Action /
Preventive Action (CAPA) incident management deficiencies.
The common pitfalls and challenges of a CAPA Incident
Management system include:
Inability to link related problems
Inconsistent investigation process
Confusion over the difference between Corrective Action and Preventive Action
Time-consuming approval process
Changes to the action plan mid-stream
No means to generate metrics
Benefits of MAXLife's CAPA Incident Management
non-conformances and record all relevant incident
Automate the processes of assigning
non-conformances, investigations, and corrective actions.
Improve management of incidents and
non-conformances with root cause analysis and real-time trend
reporting on quality issues.
Streamline compliance with FDA regulations.
Improve brand loyalty and customer
satisfaction by continuously improving quality and
responding quickly to potential incidents.
MAXLife's Corrective Action Preventive Action (CAPA) Incident Management capabilities enable you to increase control and assuredness for how your organization operates. With
MAXLife, you can generate a Corrective Action or Preventive Action request that routes through review, root cause, corrective action taken, and verification stages. This Corrective Action tracking software generates multiple reports automatically, providing an effective mechanism for tracking the source and costs of problems.
Using a systematic approach to correcting and preventing issues, measuring the outcome and continuously monitoring the system can ensure that a company is compliant, effective and efficient. And, having a well-thought-out
CAPA Incident Management system can result in successful audits, fewer investigations, less product loss, better customer satisfaction, and an increase in overall operational efficiencies.
MAXLife ERP can dramatically improve profitability, productivity, and product safety at even the most complex organizations.
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