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