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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…

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.…

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…

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…