The GMP software for training management
The legislator requires an efficient training management and documentation from manufacturers of medicinal products: “The manufacturer should provide training for all the personnel whose duties take them into production areas or into control laboratories….” (EU GMP Guide).
Originally developed by Boehringer Ingelheim GmbH (today Roche Diagnostics GmbH) and today used by many international pharmaceutical companies, the software PharmSchul® supports the planning, administration, analysis and documentation of pharmaceutical trainings. Due to the possibility to follow and verify the training status for every employee prior to or during a GMP inspection the software ensures a structured training planning and assessment of demands.
Flexibility for Customisation
PharmSchul is based on a powerful and flexible data structure. The modular concept allows to customise boxes, masks and data structures without changing the PharmSchul system itself – ensuring more security for future updates that are also validated.
Take further advantage of the new user administration. Display your company’s structure and define department administrators who take care of the trainings and staff in their area. Powerful reports show potential training deficits any time.
Part 11 Compliance
In 21 CFR Part 11 the FDA defined the requirements with regard to electronic records and electronic signatures. The compliance with these requirements is the pre-condition for the use in the FDA-regulated environment. PharmSchul 5.0 also translates these requirements systematically, e.g. through:
- Installation of a client/sever architecture
- PharmSchul-Audit-Trail for documenting every change implemented
- Additional security policies in the user administration
More information – as e.g. with regard to performance features and system requirements – as well as a PharmSchul demo version is available at the PharmSchul Website.
PharmSchul® is registered trademark of Concept Heidelberg GmbH, Heidelberg.