Integrating Employee Training with PLM in Medical Device Industry

In highly regulated industries , like medical devices , employee training have paramount significance.  Training employees is important for two reasons:

  • Regulatory Compliance

FDA requires medical device companies to capture all training for employees. As part of audits, FDA ensures that proper processes and systems are in place to capture training records.

  • Building necessary skillset

Since risk is very high, especially when human lives are at stake, it is absolutely necessary that

employees are adequately trained on all relevant processes and procedures. This includes whenever a new document is released or an existing document is updated in PLM.

Capturing Training Plans and History

One of the pre-requisites to execute training is that you capture training plans for each employee. This can be done by defining training profiles that align with job descriptions or roles of the employees. Once you have training profiles, you can assign these training profiles to the individual employees and then track actual training against these profiles. If you have LMS in place, you can define these profiles in LMS. Alternatively, you can define these profiles in Agile PLM.

Capturing Training Requirements in Real Time

Whenever a new SOPS/process document is ready to be released, system should enforce that all related employees are trained to this new document before this document is actually released. Once employees are trained, then system can release new document and make it accessible for every one.

Document change management processes in PLM should be enhanced to ensure that necessary training are identified and executed before new document is released. In Agile PLM,  you can enhance workflows to capture training before document is released.

Employees need to have a very intuitive interface to submit their training.

ETR Blog

Integrate with LMS

Many companies have implemented LMS system with very rich functionality to define, execute, manage, and report on training. However, documents are usually managed in PLM system. This necessitates to sync new or updated document with LMS as soon as it is ready for training in PLM. Once training is completed,  LMS can update Agile PLM about completion status so that document can be released.

Xavor offers a suite of product s in PLM space to streamline the employee training processes, especially with Agile PLM. Following two products work together seamlessly to provide an end-to-end solution:

  • Employee Training Records (ETR)
  •  xEngine

For more information,  please reach us at

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