Switch to remote audits at a medium-sized pharmaceutical company

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QFINITY CEO represented in ISPE GAMP Global Steering Committee

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Workshop to analyze the data integrity of a HPLC software

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Roll-out SAP and EWM (Extended Warehouse Management) worldwide

The SAP and EWM systems constituting the core company systems for the financial and especially the logistical processes are to be consolidated at a global pharmaceutical company. Existing legacy systems are to be replaced and their data migrated. QFINITY∞ provides…
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Change to SAP S/4HANA for a globally established SAP R/3 system of a pharmaceutical company

SAP S/4HANA is the new version of SAP that brings fundamental changes in data management and requires extensive technical customization and testing as part of a technical update. QFINITY∞ ensures the quality of the upgrade in the role of Validation…
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Definition of the general procedure for the operation and the qualification of an IT infrastructure

Many companies have individual procedures for the operation and qualification of infrastructure components, but they often do not have a centralized, unified approach. QFINITY∞ conducts training on infrastructure control requirements at a pharmaceutical company and uses it to create comprehensive…
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Introduction of SAP Governance, Risk & Compliance (GRC)

Authorization management, especially critical access and segregation of duties (SoD), are central topics of audits. Therefore, many companies introduce central solutions to technically support or control these issues. The global ERP system is particularly important here. The introduction of SAP…
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Preparation of a Service Level Agreement (SLA)

With the requirements of Annex 11, the implementation of a Service Level Agreement (SLA) between the business department and the IT department is essential. QFINITY∞ supports a pharmaceutical manufacturer in the preparation and coordination of the contents of the SLA.…
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Production optimization at a North German manufacturer of phytopharmaceuticals

QFINITY∞ accompanied the optimisation and rationalisation of the bottling and packaging line throughout the entire project phase, from the preparation of the specifications and system selection to the completion of the validation activities.…
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Workshop Audit Trail Review

Due to the requirements of Annex 11 regarding audit trail review, companies are increasingly trying to standardize their procedures. Especially with complex systems like ERP (Enterprise Resource Planning), different aspects of the system have to be considered. As part of…
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