Validation approach for statistical software

QFINITY∞ developed a strategy for achieving the compliance of SAS installations including a generic approach for the validation of study-specific and cross-study programs for a customer.…
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Introduction of a DMS with a medical manufacturer

QFINITY∞ supports a medium-sized enterprise with the requirements analysis, supplier selection, implementation (including prospective validation) of a document management system (DMS) in accordance with the requirements of 21 CFR Part 820, ISO 13485 and 21 CFR Part 11.…
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Clinical studies in medical technology

QFINITY∞ supports major manufacturers of medical technology in the validation of a clinical trial management system (CTMS) including the connection to a statistical software.…
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SAP R/3 Validation at a Medical Technology Company

A reputable manufacturer of medical technology contracts QFINITY∞ to plan and support SAP R/3 validation activities.…
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IT-Compliance at a Pharmaceutical Manufacturer

A mid-size manufacturer of pharmaceuticals contracts QFINITY∞ to plan and execute a global validation strategy for all computerized systems.…
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QFINITY∞ consults about the 21 CFR Part 11 in the U.S.

A major U.S. Pharma company commissioned QFINITY∞ for the production of an expert opinion regarding the implementation of FDA 21 CFR Part 11 / EU GMP Annex 11 for the introduction of an Electronic Clinical Supply Management system, including Interactive…
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Training und Workshop at a Contract Research Organization (CRO)

CRO contracts QFINITY∞ to plan and conduct basic training in validation of computerized GCP systems. In a supplementary Workshop, the established QM system was analyzed to identify significant weaknesses.…
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Regulatory Compliance Check bei einer Contract Research Organisation (CRO)

CRO contracts QFINITY∞ to plan and conduct regulatory compliance checks.…
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01 December 2020 | QFINITY represented with a lecture at the 13th official GAMP conference

01 December 2020 Frank Henrichmann presents the lecture: “GxP requirements and the toolbox of modern software development – lessons learned ?!” at this year’s official GAMP 5 conference. Dorint Congress Hotel Mannheim Friedrichsring 6 68161 Mannheim…
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01 July 2020 | QFINITY represented with speakers at the second 2020 seminar “Data Integrity in GMP”

01 July 2020 Data integrity in the GMP area meanwhile plays an essential role. The seamless integration into quality management, a good overview of regulatory requirements and practical handling are essential. Take the opportunity to be informed by 6 experienced…
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