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.

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,…

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…

Auditing of the GCP processes at a university KKS and its university partner organisations

A coordination centre for clinical studies in the university sector commissions QFINITY∞ with the auditing of its GCP processes. The audit also includes two partner institutes of the university who are responsible for statistics and data management and also examines…

GCP Audit of Processes and Computerized Systems at an academic CRO

An academic CRO contracts QFINITY∞ to audit its GCP processes for compliance with regulatory requirements. The audit also included the processes and validation status of computerized systems used for data management and statistical analyses.…

Auditing of the GVP processes and the underlying computer-aided systems at a pharmaceutical manufacturer

A pharmaceutical manufacturer hires QFINITY∞ to conduct a routine audit of the pharmacovigilance system to verify compliance with regulatory requirements. The audit also includes the relevant computer-aided systems that influence processes in the pharmacovigilance area, as well as the special…

Review of the effectiveness of a CSV approach using a questionnaire

QFINITY∞ was commissioned by a global pharmaceutical manufacturer to challenge its CSV validation approach, which has been in place for several years, with regard to further simplifications, optimizations and improvements (framework with templates, application in projects, support of tools used).…

Review and optimization approach to the 21 CFR Part 11 capability of a planned ERP system

A manufacturer of high-performance ceramics for dentists and dental technicians is planned to introduce a new ERP system. The 21 CFR Part 11 capability of the new system was to be considered. In addition to this, QFINITY∞ provided a workshop…

Data Management Audit of processes and computerized systems at an academic spinoff company

An academic spinoff company contracts QFINITY∞ to audit its data management processes for compliance with regulatory requirements. The audit also included the processes and documentation concerning the underlying computerized systems, including their validation status.…

Validation of a laboratory process in a contract research organization

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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