Case Study: Gedeon Richter achieves streamlined pharma systems validation and regulatory compliance with Intland Software (codeBeamer ALM)

Gedeon Richter chose codeBeamer ALM to test, document, and validate its pharma process control & automation systems

Gedeon Richter, a Hungarian multinational pharmaceutical and biotechnology company, faced growing pains in validating computerized manufacturing process control and automation systems at its Debrecen biopharma plant. Relying on paper-based tracking created thousands of pages of documentation, made sharing, version control, reviews and regulatory sign-offs slow and error-prone, and left the company without clear, enforceable workflows or granular visibility into responsibilities and progress.

In 2018 GR adopted codeBeamer ALM, chosen for its fit with pharmaceutical processes and compliance needs, to digitize testing, documentation and validation (including IQ/OQ and validation reporting) and to collaborate with suppliers. The platform delivered enforced workflows, end-to-end traceability, complete audit trails and real-time task monitoring, improving team collaboration, reducing cycle times, and achieving broad adoption across the automation, QA and operations teams while enabling a planned central codeBeamer infrastructure for the plant.

Gedeon Richter