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Archive for category: News

1

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. […]

2

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 […]

4

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.

7

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 […]

8

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.

10

Workshop Audit Trail Review

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 […]