What is a Training Management System TMS as per cGMP?

The FDA requires medical device and drug manufacturers to maintain trained employees in a predetermined frequency.

Its requirement is defined in 21 CFR 211.25 for pharmaceuticals and 21 CFR 820.25 for Medical Devices.

It states that “companies must ensure that their personnel has the education, training, and experience, to perform their assigned duties.”

The FDA allows you to establish your training program manually or electronically.

In either case, you can use cGMP training procedure templates or Training Management System Software Applications.

THE TOP 6 TYPES OF TRAINING ARE:

1. e-learning,
2. online,
3. computer-based,
4. self-training
5. classroom, or
6. simulator learning environments.

A training management system is a program either manual or electronic intended for the administration, documentation, tracking, and reporting of instructor-led tuition programs.

Some companies use dedicated software for this purpose, other companies handle their training management system more manually.

The TMS includes the control and handling of all training records of the organization’s employees.

A TMS manages instructor-led training administration, session registration, course administration, tracking, effective monitoring, and reporting.

In some cases, they are capable to manage financial aspects, including budget forecasting and cost-tracking.

TMSs can be complemented by a learning management system for e-learning management and course delivery.

The first step to implement a Training Management System is reviewing your Quality Management Systems procedures.  In case you need help to create or improve your Quality Management procedures, consider using one of our template documents.  To see the complete list of the most popular Quality Management procedures templates, click here.