Oliver Herrmann (CEO of QFINITY) and Frank Henrichmann (Sr. Executive Consultant at QFINTIY) have been members of the global ISPE GAMP Steering Committee for several years.

Now both have received the Committee of the Year award from ISPE.
The ISPE GAMP Community of Practice received this award at the 2022 ISPE Annual Meeting & Expo in Orlando for creating GAMP 5 Second Edition.

Both have deserved this award. Congratulations!

https://www.linkedin.com/feed/update/urn:li:activity:7043633392462000128

https://www.linkedin.com/feed/update/urn:li:activity:7043966967065497600

Marcus Schwabedissen (COO of QFINITY) has been a very dedicated member of ACDM for many years. Now he and his team “DMEG eDigital” have won third place in the award for the most successful team.

We would like to offer our sincere congratulations. This award is well deserved.

 

https://www.linkedin.com/pulse/dmeg-edigital-won-third-place-most-successful

 

Despite pandemic conditions, compliance monitoring of partners and vendors is possible. QFINITY has supported the adaptation of a pharmacovigilance audit program from an on-site to a remote audit model at a medium-sized pharmaceutical company. Due to travel restrictions, QFINITY is supporting the same manufacturer in conducting remote audits to monitor pharmacovigilance agreements with partners worldwide. […]

Mr. Oliver Herrmann, founder and CEO of QFINITY, is an internationally acknowledged expert on validation, technology quality, data integrity and system implementation. His extensive knowledge and expertise as well as his unwavering energy and passion for quality have enabled him to become a key contributor to the ISPE GAMP organization. Oliver leads an international GAMP […]

To define requirements for the software provider and internal processes for the implementation of a new HPLC software, QFINITY∞ leads a workshop to analyze the data, processes and planned infrastructure.

The SAP and EWM systems constituting the core company systems for the financial and especially the logistical processes are to be consolidated at a global pharmaceutical company. Existing legacy systems are to be replaced and their data migrated. QFINITY∞ provides the project quality assurance for change management, document life cycle, testing and data migration.

SAP S/4HANA is the new version of SAP that brings fundamental changes in data management and requires extensive technical customization and testing as part of a technical update. QFINITY∞ ensures the quality of the upgrade in the role of Validation Manager, which also includes the development of a plan for running parallel versions and, in particular, for updating the validation documents. The SAP smartShift Tool is used, which allows a semi-automatic modification of the source code and whose qualification is part of the project.

Many companies have individual procedures for the operation and qualification of infrastructure components, but they often do not have a centralized, unified approach. QFINITY∞ conducts training on infrastructure control requirements at a pharmaceutical company and uses it to create comprehensive SOPs and templates

Authorization management, especially critical access and segregation of duties (SoD), are central topics of audits. Therefore, many companies introduce central solutions to technically support or control these issues. The global ERP system is particularly important here. The introduction of SAP Governance, Risk & Compliance (GRC) has become an elementary component of the SAP lifecycle, as processes such as change management can be supported centrally and system-oriented. QFINITY introduces SAP CHaRM (Change Request Management) for various SAP systems around the world at one of the leading pharmaceutical manufacturers as a technical expert and project manager.

With the requirements of Annex 11, the implementation of a Service Level Agreement (SLA) between the business department and the IT department is essential. QFINITY∞ supports a pharmaceutical manufacturer in the preparation and coordination of the contents of the SLA.