Working Sets: Working with existing Working Sets
Intland Software is proud to announce the release of a new customer success story with Gedeon Richter, a Hungarian multinational pharmaceutical and biotechnology company. The team in Gedeon Richter’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.
Established in 1901, Gedeon Richter is today one of the largest pharma & biotech companies in the CEE region with over 12,000 employees worldwide. Operating in the pharmaceutical innovation and manufacturing space, Richter uses sophisticated computerized production automation and control systems in its manufacturing plants. Since 2018, the company’s plant in Debrecen, Hungary validates its systems and ensures adherence to GAMP, Title 21 CFR Part 11, and Annex 11 compliance requirements with the help of codeBeamer ALM.
Prior to making the digital transition, this Gedeon Richter team relied on a paper-based system to manage and track their validation efforts. The volume and complexity of these paper records made collaboration difficult. Sharing, reviewing, and signing off on documents was a manual and thus error-prone process.
Upon making the switch to codeBeamer ALM, the company gained a powerful collaborative system to clearly define, enforce, and track workflows. The platform gives them detailed insights into responsibilities, deliverables, and work progress, simplifying work management and accelerating compliance preparation & audits. This GR team now enjoys traceability and complete change control across their validation processes, and was able to discover bottlenecks and to reduce cycle times with the help of codeBeamer ALM.
To learn more about how this pharma & biotech company’s validation team transitioned to a collaborative, digital validation & workflow control system, and the benefits they experience, access Intland Software’s Gedeon Richter customer success story free of charge at https://intland.com/case-studies/.
