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Gedeon Richter: A Pharma & Biotech Use Case for Systems Validation

richter_gedeon_success_story_featured_imageOur latest success story analyzes the use case of Gedeon Richter, a multinational pharmaceutical development and biotechnology company based in Hungary. The company’s biopharmaceutical plant in Debrecen, Hungary selected codeBeamer ALM to manage the testing, documentation, and validation of its computerized pharma manufacturing process control & automation systems. The team uses codeBeamer ALM to successfully comply with GAMP, 21CFR11, and Annex 11 requirements.

Intland Software’s solutions are effectively used by safety-critical product developers around to world to simplify delivery and to ensure regulatory compliance. In the pharmaceutical & biotech industry, there’s the additional challenge of validating and documenting the computerized systems that support manufacturing process control and automation.

Digital validation with Intland’s software tool

Like most companies, Gedeon Richter (GR) had used a paper-based system for testing, validation, sign-offs, and documentation before going digital. In the highly complex environment that pharma companies operate in, even the physical handling of that volume of documentation can be challenging: with several thousands of pages, you could easily imagine GR’s paper trails blocking a corridor. Naturally, physical storage wasn't the primary issue that necessitated the use of a digital tool.

The collaborative management of documentation (including sharing, reviewing, and sign-offs) in compliance with relevant regulations was difficult. Gedeon Richter needed a solution to ensure adherence to the requirements of the Good Automated Manufacturing Practice, FDA’s Title 21 CFR Part 11, and GMP Annex 11.

In 2018, the automation team at the company’s Debrecen, Hungary plant started evaluating tools, and ended up selecting codeBeamer ALM. The platform was chosen for its high adaptability to pharma use cases, and its ability to support regulatory compliance.

Tool value

This Gedeon Richter team reported a variety of benefits after going digital with their validation processes using codeBeamer ALM. Among these, overall improvements in transparency, process control, and team collaboration were the most important. The real-time monitoring and change control provided by the system are highly valued by the GR team, as is collaborative document management. The team loves codeBeamer ALM, and is currently working on building a central infrastructure for this Debrecen plant to expand the platform’s use.

To learn more the use case of this multinational pharmaceutical & biotech company, and how Gedeon Richter uses codeBeamer ALM in its validation efforts, access the customer success story free of charge!

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Customer Success Story: Gedeon Richter