Q_NEWS

Here we keep you up to date with the latest news on developments, trends and innovations. As a leading consulting company, we offer you well-founded insights, expert analyses and practice-oriented information on a wide range of topics.

Search here for news on topics such as GxP, pharma, quality management and news on GAMP or read the news from our company.

Review and streamlining of IT SOPs at a pharma company

Pharmaceutical company commissions QFINITY∞ to significantly “slim down” the IT-SOP landscape. This means that documents are to be reduced both in number and in scope without jeopardizing the regulatory resilience.…

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.…

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.…

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.…

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.…

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.…

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…

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.…

Regulatory Compliance Check bei einer Contract Research Organisation (CRO)

CRO contracts QFINITY∞ to plan and conduct regulatory compliance checks.…

You are also welcome to find out about news from the ISPE and ACDM. QFINITY is very active in both international organizations and is involved in numerous projects.

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