PharmSchul 5.0 is a powerful and flexible database system used for planning, managing, reporting and documenting training.
PharmSchul is a registered trademark of
Concept Heidelberg GmbH.
In accordance with the regulatory requirements with PharmSchul it is possible to plan, document and report training for operational staff.
Of course every other type of training can be documented in PharmSchul.
In addition to the convenient and user-friendly management functions, PharmSchul offers plenty of reports and controlling instruments.
On one hand side the reports meet the regulatory requirements to confirm the employee's qualification and on the other hand side the reports
are an organizational tool for documenting and planning the education of personnel.
An outstanding feature of PharmSchul is the fact, that it is based on a configurable data base and allows the adding of fields in all
folders - even the adding of new folders, tables, functions and reports is possible.
Individual customizing is possible at any time!
21 CFR Part 11 conatins the FDA's definition of requirements for electronic records and electronic signatures.
Compliance with these requirements is a prerequisite for the usage of PharmSchul in the FDA regulated environment. PharmSchul meets these requirements.
The system is qualified for all companies, that need to implement an electronic training management system, which fulfills the requirements of GMP regulations.
Beside the pharmaceutical companies, these are also manufacturers of medical devices, active pharmaceutical ingredients and the cosmetic industry.
- Installation in a Client/Server-architecture for a maximum of security (either with or without a SQL-Server).
The PharmSchul Audit-Trail documents any change.
Additional security policies in the PharmSchul user management.
PharmSchul is validated based on GAMP 5 guide.
GAMP 5 and also Good Practice Guides (GPG) is the world wide accepted standard for validating computerized systems.