GCP Audit of Processes and Computerized Systems at an academic CRO

An academic CRO contracts QFINITY∞ to audit its GCP processes for compliance with regulatory requirements. The audit also included the processes and validation status of computerized systems used for data management and statistical analyses.…
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Auditing of the GVP processes and the underlying computer-aided systems at a pharmaceutical manufacturer

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…
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Review of the effectiveness of a CSV approach using a questionnaire

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).…
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Review and optimization approach to the 21 CFR Part 11 capability of a planned ERP system

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…
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Data Management Audit of processes and computerized systems at an academic spinoff company

An academic spinoff company contracts QFINITY∞ to audit its data management processes for compliance with regulatory requirements. The audit also included the processes and documentation concerning the underlying computerized systems, including their validation status.…
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Validation of a laboratory process in a contract research organization

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…
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Audit of the Quality Management Processes of a small/midsize CRO

A small-to-midsize CRO contracts QFINITY∞ to conduct an audit of the quality management system in order to identify opportunities for improvement. The audit comprised all the processes associated with the QM unit and its documentation.…
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Audit of the GCP Safety Processes and the underlying computerized systems of a small/midsize CRO

A small-to-midsize CRO contracts QFINITY∞ to conduct an audit of the safety processes and the underlying computerized systems. The audit included an assessment of the validation status of the pharmacovigilance software in use at the CRO.…
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Approach to the Qualification of IT infrastructure

In the context of centralizing its IT services, a pharmaceutical manufacturer has contracted Q-FINITY to support the implementation of an approach for qualifying the IT infrastructure. QFINITY∞ provides coaching through client workshops in order to provide basic knowledge as a…
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Data Integrity – Workshop and Gap Analysis

An API manufacturer wishes to conduct a data integrity analysis in preparation for an FDA audit planned for the mid-term. QFINITY∞ is training the client in the basics concerning GxP, CSV and data integrity and is analyzing the systems (automation,…
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