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In highly regulated industries such as the medical device industry, employee training with agile plm has 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, the FDA ensures that proper processes and systems are in place to capture training records.

Building a Necessary Skill set

Since the 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 Agile PLM.

Capturing Training Plans and History

One of the prerequisites 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 the training profiles created, you can assign these training profiles to the individual employees and then track the actual training against these profiles. If you have an 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 SOP/process document is ready to be released, the system should enforce that all related employees are trained to this new document before this document is actually released. Once all employees are trained, then the system can release a new document and make it accessible for everyone.

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

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

Integrate with LMS

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

Xavor offers a suite of solutions within the Agile PLM space to streamline employee training processes.

The following Xavor solutions work together seamlessly to provide an end-to-end solution:

Employee Training Records (ETR)
xEngine

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Faisal Saeed

Faisal Saeed is the Vice President of IT Services of Xavor Corporation with 20 years of experience in Software Development. His areas of interest include Workflows/Business Process Automation, Integration, and Enterprise Web Development. He specializes in dissecting requirements and coming up with intuitive solutions. You can connect with him on LinkedIn.