With the requirements of Annex 11, the implementation of a Service Level Agreement (SLA) between the business department and the IT department is essential. QFINITY∞ supports a pharmaceutical manufacturer in the preparation and coordination of the contents of the SLA.
QFINITY∞ accompanied the optimisation and rationalisation of the bottling and packaging line throughout the entire project phase, from the preparation of the specifications and system selection to the completion of the validation activities.
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 the launch of a new ERP system, QFINITY∞ collaborates with a pharmaceutical company to define a process for this activity.
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.
