If you are not happy with the results below please do another search
Our medical technology client wants to establish the electronic batch record as the central tool for production documentation (including archiving). The contracted audit is intended to verify the regulatory compliance (USA / EU) of the implementation project, the computerized processes for producing an electronic batch record and the implementation of the process in an electronic […]
Strategic and operative support for a project to impelement a system landscape for automated transfer of product information to the FDA. The project was intended to create a technological foundation for facilitating the automated transfer of product data from an SAP system tot he GUDID of the FDA via an external gateway.
Medical technology company contracts QFINITY∞ to plan and conduct online training sessions for employees of its IT departments, including modification of the existing training materials for online training.
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.
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.
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.
QFINITY∞ supports major manufacturers of medical technology in the validation of a clinical trial management system (CTMS) including the connection to a statistical software.
A reputable manufacturer of medical technology contracts QFINITY∞ to plan and support SAP R/3 validation activities.
A mid-size manufacturer of pharmaceuticals contracts QFINITY∞ to plan and execute a global validation strategy for all computerized systems.
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 Voice & Web Response Services (IVRS / IWRS ).
