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 ).

CRO contracts QFINITY∞ to plan and conduct basic training in validation of computerized GCP systems. In a supplementary Workshop, the established QM system was analyzed to identify significant weaknesses.

CRO contracts QFINITY∞ to plan and conduct regulatory compliance checks.