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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Data Governance and Data Integrity at a large pharmaceutical company

QFINITY∞ creates the basis for the establishment and implementation of a comprehensive set of guidelines for the company-specific and effective fulfillment of data governance and data integrity requirements in a large, corporate-affiliated pharmaceutical company.…
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Track & Trace for a phytopharmaceutical manufacturer

QFINITY∞ supports the introduction and implementation of a concept for the regulation-compliant introduction of “track and trace”. Based on the legal requirements, a concept was developed in close cooperation with the client, which would also allow smaller manufacturers an economical…
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Development of a validation framework and validation of Open-Source EDC software for a European physicians’ association

A European contract research organization (CRO), associated with an association of European physicians, needed to validate its Open-Source data collection system (EDC) for conducting clinical trials. QFINITY∞ trained the organization’s employees in the basics concerning GxP, CSV and Part 11,…
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Auditing the clinical data management process of a university institute

A university institute (CRO) wished to perform clinical trials with an Open-Source electronic data capture (EDC) system. QFINITY∞ was commissioned by the QA department of the university to perform an audit concerning the compliance of the validation project and the…
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