MAXLife: Life Sciences Cloud ERP

MAXLife Cloud - CAPA Incident Tracking and Management

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 deficiencies.

The common pitfalls and challenges of a CAPA 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

MAXLife Cloud's Correction Action Preventative Action (CAPA) 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 the 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 system can result in successful audits, fewer investigations, less product loss, better customer satisfaction, and an increase in overall operational efficiencies.

MAXLife Cloud ERP benefits:

Real-Time Visibility Into Critical Business Data

FDA Compliance Support and Validation

Powerful Embedded BI and Analytics

Support for Global, Multi-Site Organizations

Automate and Optimize Business Processes

Agile and Flexible Deployment Alternatives

Complete Supply Chain Integration

Low Total Cost of Ownership

Simple, Familiar, and Intuitive User Experience

What Can Cloud ERP Do For You?

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CEOs Finance IT Sales Operations

Free MAXCloud ERP Trial

Life Sciences Industry Webinar

MAXCloud ERP Fact Sheet 

This paper presents a practical and compliance-focused approach to root cause analysis and corrective action processes.

  Failing To Establish and Maintain a CAPA System? Your Company Could be at Risk

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