Zamann Pharma Support was engaged by a multinational pharmaceutical company (German facility), to lead a critical validation project step, related to the implementation of Labware LIMS 8 at one of their German manufacturing sites. This part of the scope included: creation of Test Plans covering System Processes and Master Data, and managing their lifecycle within Micro Focus ALM (software used to execute, track, and report computerized system validation (CSV) tests). The project aimed to ensure regulatory compliance (GxP, FDA, EU Annex 11) and system readiness for routine operations.
The client’s internal teams were overloaded with concurrent strategic projects and lacked the in-house resources and expertise to handle complex CSV test development and execution processes in a structured manner. In addition, the Labware LIMS 8 configuration involved diverse and highly customized workflows that required extensive validation coverage. Ensuring cross-functional stakeholder alignment and timely approvals within ALM posed further difficulties, especially given the international coordination required across QA, IT, and user teams.
Zamann deployed a senior CSV consultant with more than 10 years of experience in CSV to assess test needs based on URS and system configurations. All test cases were designed in Excel templates following GAMP5 and company SOPs. These were uploaded and structured into ALM, ensuring traceability to requirements and risk assessments. Zamann led the full approval workflow within ALM, coordinated dry-runs, and provided real-time support to testers throughout the execution phase, mitigating errors, addressing deviations, and ensuring accurate documentation.
The project was delivered within the agreed timeline and passed internal Quality Assurance reviews without any observations. Over 100 test cases were created, reviewed, and executed with full traceability in ALM, enabling successful validation of Labware LIMS 8. It was clear that the reduced number of errors and deviations was a result of Zamann´s structured methodology and collaborative approach. The project reinforced the site’s compliance readiness ahead of an upcoming regulatory inspection.
“Zamann Pharma Support played a critical role in our LIMS8 validation project. Their technical expertise and deep understanding of ALM and CSV requirements helped us to perform this complex implementation with confidence. Their consultant integrated with our team, ensuring the Quality and integrity of our validation process. We highly recommend Zamann for any pharmaceutical organization aiming for excellence in system validation.”
