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Review and streamlining of IT SOPs at a pharma company

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.…

Validation approach for statistical software

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.…

Introduction of a DMS with a medical manufacturer

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.…

Clinical studies in medical technology

QFINITY∞ supports major manufacturers of medical technology in the validation of a clinical trial management system (CTMS) including the connection to a statistical software.…

SAP R/3 Validation at a Medical Technology Company

A reputable manufacturer of medical technology contracts QFINITY∞ to plan and support SAP R/3 validation activities.…

IT-Compliance at a Pharmaceutical Manufacturer

A mid-size manufacturer of pharmaceuticals contracts QFINITY∞ to plan and execute a global validation strategy for all computerized systems.…

QFINITY∞ consults about the 21 CFR Part 11 in the U.S.

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…

Review and streamlining of IT SOPs at a pharma company

Validation approach for statistical software

Introduction of a DMS with a medical manufacturer

Clinical studies in medical technology

SAP R/3 Validation at a Medical Technology Company

IT-Compliance at a Pharmaceutical Manufacturer

QFINITY∞ consults about the 21 CFR Part 11 in the U.S.

Training und Workshop at a Contract Research Organization (CRO)

Regulatory Compliance Check bei einer Contract Research Organisation (CRO)

01 December 2020 | QFINITY represented with a lecture at the 13th official GAMP conference