Training Management System Software Application

Powerful Tools and Security Controls (21 CFR Part 11 Compliant)em software

This application facilitates the identification, execution, documentation, and evaluation of the effectiveness of training activities. Moreover, it brings the mechanism to document the training history records of each trained person and register its signature in a signature log.

It provides the power and capability to improve the Training documentation control activities to comply efficiently with the cGMP’s and regulatory compliance requirements.  It is specifically designed for the pharmaceutical, biotechnology, and medical devices industries that want to reach the top level in competitiveness.

Application Software Features

It applies to any department that provides or performs any GxP training (e.g. human resources department, manufacturing, quality, incoming, warehouse, etc).

Besides, the scope of this procedure cover two (2) different scenarios or groups of training, specifically for:

1. New Hires Resources: Resources that start working for the company for the first time and must be trained with the necessary information to perform their work.
2. Existing Resources: This group of training is divided into two (2) scenarios, either associated with a work order or not:

• • New Training: This group considers the training requirements have never been taken and are necessary to perform any GxP task.
  • Re-Training: This group considers the training requirements that have been taken before, but; maybe refreshed since the last time before performing any current GxP task that even it has been done before, but it needs to be confirmed and documented as re-training.