Switch to remote audits at a medium-sized pharmaceutical company

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. […]

QFINITY CEO represented in ISPE GAMP Global Steering Committee

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 […]

Workshop to analyze the data integrity of a HPLC software

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.

Roll-out SAP and EWM (Extended Warehouse Management) worldwide

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.

Change to SAP S/4HANA for a globally established SAP R/3 system of a pharmaceutical company

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 […]

Definition of the general procedure for the operation and the qualification of an IT infrastructure

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

Introduction of SAP Governance, Risk & Compliance (GRC)

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 […]

Preparation of a Service Level Agreement (SLA)

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.

Production optimization at a North German manufacturer of phytopharmaceuticals

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.