MAXLife: CAPA Incident Management ERP Software

MAXLife ERP > Life Sciences Business Challenges > Track Incidents and Non-Conformances

I need to track incidents and events through the cycle of root cause identification, corrective action and preventive actions put in place.

Life Sciences companies are required to detect and react to incidents and to ensure that appropriate actions are taken. This is an area the FDA always scrutinizes during manufacturing facility inspections. Managing or mismanaging CAPA documents in disparate or paper-based systems can yield to citations for violating current good manufacturing practices (cGMP).

MAXLife ERP integrates a company’s business processes to improve operational efficiencies, reduce compliance risks, and streamline collaboration. MAXLife's enables 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.

Within MAXLife, Life Sciences companies can use one end-to-end system to:  

  • Track incidents

  • Analyze root causes

  • Develop corrective actions

  • Write and approve reports

  • Track and validate the effectiveness of fixes

  • Trend performance

MAXLife provides the capability to track all non-conforming material, maintain an accurate database including disposition information, and produce the required FDA reporting documents.

MAXLife ERP can dramatically improve profitability, productivity, and product safety at even the most complex organizations. Contact Merit Solutions to learn more about MAXLife ERP.

Failing to Establish and Maintain a CAPA System