In highly regulated industries such as the medical device industry, employee training has paramount significance.
Training employees is important for two reasons:
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.ds.
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:
As Xavor’s Managing Consultant with more than 12 years of experience, Saeed has worked with various industries from high-tech manufacturing to medical device. Saeed’s focus has been primarily on integration and portal solutions around PLM systems.