Navitas pharmaREADY TRMS is a web-based Training Records Management System specifically designed for Life Science organizations where ease of installation, ease of use, regulatory compliance, and affordability are the primary business drivers. It meets current regulatory standards while also allowing for best practice processes to be employed.
21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals states that training in standard operations for each employee must be provided to ensure all employees are properly qualified to complete their assigned work tasks. The management of technical training and maintenance of a comprehensive and accurate training records file for each employee can present as a daunting task. pharmaREADY TRMS manages the entire process and provides the tools to ensure your employees are adequately trained while maintaining the required compliance documentation.
Navitas pharmaREADY TRMS is designed specifically for the management of training related to SOPs, Work Instructions, and other Specifications documents within business areas regulated by the FDA. It can also be used for documenting any other employee training as needed.
Key pharmaREADY TRMS features include:
- Email notifications to both Employees and Supervisors about any upcoming training that may be required
- Customizable, on-line assessments with results automatically reported to the Supervisor and stored in the Employee's training record
- Automatic notification of retraining when Specifications are updated
- e-Signatures for updating training records when needed
- Training management at the Employee, Supervisor, and/or Department level
- Executed Installation and Operational Qualification documents
- Administration Manuals
pharmaREADY TRMS System is available as an independent product or is easily tightly integrated with other pharmaREADY products including pharmaREADY DMS.