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). A comparison of the method with other companies was also to be carried out. For this purpose, QFINITY∞ created a comprehensive questionnaire, which is used to conduct interviews at the international level with people from different divisions and roles (business departments, IT, QA, external consultants of the customer). On the basis of the prepared results, detailed recommendations on the individual topics are proposed.
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 for the elaboration and the recommendations that should be taken into account regarding Part 11 in the new 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 for the elaboration and the recommendations that should be taken into account regarding Part 11 in the new system.
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.
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 foundation for QFINITY∞‘s ongoing support.
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, laboratory and IT) in order derive an action plan to ensure conformity with requirements.
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 supporting role, for example in analyzing the requirements, in performing risk analyses and in ensuring GxP-compliant implementation of the system (Audit Trail, handwritten signatures on electronic devices). A GxP-compliant template is being created for worldwide rollout (multi-site approach).
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 for this project.
