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.
We support pharmaceutical teams in implementing, maintaining, and optimizing GMP software, data management systems, and computerized workflows that strengthen compliance, data integrity, and operational efficiency.
Using templates aligned with GAMP5 and SOPs, test cases can be designed systematically in Excel and uploaded to ALM, ensuring traceability to requirements and reducing errors during execution.
Centralizing workflow management in ALM, conducting dry-runs, and providing real-time support ensures timely approvals, stakeholder alignment, and accurate documentation across QA, IT, and user teams.
Structured test planning, risk-based validation, and full traceability in ALM enable accurate documentation, minimize deviations, and strengthen readiness for regulatory inspections (GxP, FDA, EU Annex 11).
