Shaping the regulated quality of tomorrow.

A globally positioned service provider, grown through acquisitions, needed a single QMS for IT and computerized systems. QFINITY harmonized the processes in line with GAMP 5 and ITIL – from concept through the design and documentation of individual processes to a global rollout with workshops and training materials.

The project

This project centered on creating a global quality management system.

QFINITY supported a global service provider that had grown significantly through acquisitions in harmonizing and rolling out a uniform quality management system worldwide, covering all areas of IT and computerized systems.

This covered processes and services in infrastructure management, software development and the implementation of computerized systems. Because the service provider’s portfolio includes products and services in all GXP areas, the approach had to satisfy all relevant regulations. The quality management system also had to build on standards such as GAMP 5 and ITIL. QFINITY helped develop the QMS concept and design and document the individual processes within it. QFINITY also supported the global rollout with training materials, workshops and targeted consulting for individual areas.

Harmonization succeeds with a ‘best of breed’ approach – it builds on what works and earns acceptance.

The goal

The project’s overall objective was to develop, harmonize and implement a comprehensive, uniform Quality Management System (QMS) worldwide. The system was designed to cover all areas of IT and the computerized systems used throughout the company, so that the same quality standards would apply worldwide. All departments and locations were to benefit from consistent, optimized processes. The QMS was meant to provide a basis for standardizing quality processes, increase efficiency within the IT structure and at the same time keep all technical processes reliable and stable.

A particular focus was developing a flexible QMS that could adapt to the specific requirements of different IT areas – without compromising global standards or regulatory requirements. Central harmonization makes processes and guidelines more transparent, which supports the company’s continuous improvement process. Training and clear instructions were to enable all employees, regardless of location or IT department, to use the system efficiently and correctly.

Beyond increasing efficiency and compliance with global quality standards, the project minimizes the risks that country-specific deviations in the IT infrastructure could create. The new QMS thus serves as a global reference framework that ensures a high level of quality, security and consistency across all company processes. This lets the company respond with greater agility to regulatory and technological change.

Any questions about creating a global QMS?

What are the critical success factors when implementing a global QMS?

• The following factors are of particular importance when implementing a global QMS:
• Support from all relevant stakeholders, especially management: implementation only succeeds if everyone involved knows it is being carried out on behalf of and with the backing of management. Everyone also needs to understand why a harmonized Quality Management System is being implemented. The reasons may include
  • To ensure regulatory compliance
  • to fulfill customer expectations
  • and thus ensure the long-term success of the company.
• Training and consulting for all affected areas: Creating and implementing the relevant standard operating procedures is only a first step in implementing a Quality Management System. The affected departments and their employees need thorough training in the new processes and the requirements behind them. Some areas may also need individual consulting services, for example to establish initial compliance for complex and critical systems.

What initial obstacles do you have to expect in a project like this?

• One initial obstacle is the different terminology established in individual areas. A universally recognized glossary helps overcome misunderstandings and terminology problems.
  It also pays to analyze the existing quality management processes and find a balanced “best of breed” approach that picks up processes already established in parts of the company, harmonizes them and then rolls them out across the entire company. This increases acceptance among employees, as they recognize at least parts of their familiar processes.

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