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.

QFINITY∞ accompanied the optimisation and rationalisation of the bottling and packaging line throughout the entire project phase, from the preparation of the specifications and system selection to the completion of the validation activities.

Due to the requirements of Annex 11 regarding audit trail review, companies are increasingly trying to standardize their procedures. Especially with complex systems like ERP (Enterprise Resource Planning), different aspects of the system have to be considered. As part of the launch of a new ERP system, QFINITY∞ collaborates with a pharmaceutical company to define a process for this activity.