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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Implementation of a Field Service Management Solution based on Salesforce

To support its Field Service Management a medical device manufacturer planst o implement a software solution based on Salesforce basierenden Software-Lösung. The goal is primarily to collect information on key indicators. In the context of this project, QFINITY∞ has a…
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SAP Release Change at a pharmaceutical manufacturer

The client plans to upgrade his SAP system landscape (using SAP S/4HANA in-memory database technology) and wants use this opportunity to improve the company’s approach to implementation, validation and operation of these systems. QFINITY∞ will provide strategic and conceptual support…
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Audit of an electronic batch record (EBR)

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…
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Implementation and Validation of an UDI-Solution

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…
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