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.
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 way to meet legal requirements.
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, and provided the necessary SOPs and templates for validation and operation, while supporting the ongoing validation of the EDC system (OpenClinica) by coaching.
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 validation documents for the EDC system, as well as other regulatory documents necessary for conducting clinical trials.
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 the computerized systems used and their validation.
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 role of a qualified person in the company.
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). A comparison of the method with other companies was also to be carried out. For this purpose, QFINITY∞ created a comprehensive questionnaire, which is used to conduct interviews at the international level with people from different divisions and roles (business departments, IT, QA, external consultants of the customer). On the basis of the prepared results, detailed recommendations on the individual topics are proposed.
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 for the elaboration and the recommendations that should be taken into account regarding Part 11 in the new system.
