In a recent project we increased the efficiency, quality and consistency of Project Quality Management (PQM) in a global pharmaceutical company.

The starting position

For historical reasons, the role of the project quality manager was originally based in the department-specific IT organizations of the Group's subsidiaries. As part of the company's new IT operational structure, this role was to be transferred to a new function providing IT services for cross-departmental business processes. This new function is also responsible for the quality management of all global, regional and local IT projects that support comprehensive applications to support GxP-regulated business processes such as manufacturing, quality compliance and quality assurance. As such, these applications are subject to Computerized System Validation (CSV) and Information Management Governance (IMG) regulations.

Datalynx has therefor developed an integrated and standardized approach to processes, people and tools for future projects. These end-to-end PQM services enable the seamless and timely delivery of products to customers and patients.

What we have achieved

• Establishment of a complete PQM service model, which not only streamlines and standardizes all existing PQM services, but also extends the range of services offered (e.g. introduction of monitoring and KPI reporting)
• Increasing the effective quality and efficiency of PQM services
• Strengthening the PQM role within the company to ensure continued compliance with CSV and IGM
• Introduction of a service quality management system to measure service quality on the basis of key quality indicators
• Reduction of the total costs of the project