Guiding documents and records

Process descriptions, documents and records are used to guide the implementation of daily workflows and the leading and supporting processes. The targeted control of documents and records is intended to ensure the fulfillment of defined requirements for the management system and the effectiveness of the system.

Processes and documents are created via a digital document management system, approved and distributed via a defined approval workflow. Each employee only has access to currently valid processes and documents. Special editing rights are required to design processes and documents or make changes. If the revision status is changed, the old document is automatically archived. In addition, GxP-compliant archiving takes place in a validated document management system for at least 15 years. The archiving requirement also applies to all verification documents generated as part of quality management, either in digital form or GxP-compliant paper archiving in an external GLP archive.