Creation of a global quality management system

The project

This project involved the creation of a global quality management system.

QFINITY supported a global service provider, which had grown significantly through acquisitions, in the harmonization and global implementation of a uniform quality management system for all areas of IT and computer systems.

This included processes and services in the areas of infrastructure management, software development and the implementation of computerized systems. As the service provider has products and services in all GXP areas in its portfolio, an approach had to be found that satisfactorily supports all relevant regulations. Furthermore, the quality management system had to be based on standards such as GAMP 5 and ITIL. QFINITY supported the creation of the QMS concept as well as the design and documentation of the individual processes within the QMS. QFINITY also supported the global implementation with training materials, workshops and individual consulting services for individual areas.

The goal

The overall objective of the project was the development, harmonization and worldwide implementation of a comprehensive and uniform Quality Management System (QMS). This system was to be designed to cover all areas of IT and the computer systems used throughout the company. This measure was intended to ensure that the same quality standards were applied worldwide. It was important to ensure that all departments and locations benefit from the consistent and optimized processes. The QMS should create a basis that makes it possible to standardize quality processes. It should also increase efficiency within the IT structure and at the same time ensure operational reliability and stability in all technical processes.

A particular focus was on the development of a flexible QMS that could be adapted to the specific requirements of different IT areas. Care had to be taken to ensure that global standards and regulatory requirements were not compromised in the process. Central harmonization increases the transparency of processes and guidelines, which supports the company’s continuous improvement process. All employees, regardless of location or specific IT department, should be enabled to use the system efficiently and correctly through training and clear instructions.

In addition to increasing efficiency and compliance with global quality standards, the project is designed to minimize the risks that could arise from country-specific deviations in the IT infrastructure. The new QMS thus serves as a global reference framework that ensures that a high level of quality, security and consistency is achieved in all company processes. This enables the company to react more agilely to regulatory and technological changes.

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: successful implementation is only possible if it is clear to everyone involved that the implementation is being carried out on behalf of and with the support of management. In this context, the reasons and necessities for implementing a harmonized Quality Management System HS must also be clearly communicated to everyone. The reasons and necessities 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: The creation and implementation of the relevant standard operating procedures is only a first step for the implementation of a Quality Management System HS. The relevant departments and their employees must be comprehensively trained in the new processes and the underlying requirements. For relevant areas, it may be necessary to provide individual consulting services, for example to ensure 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 that is established in individual areas. The creation of a universally recognized glossary helps to overcome difficulties in understanding and terminology problems.
  Furthermore, it is advisable to analyse the existing quality management processes and find a balanced “best of breed” approach that takes up processes already established in parts of the company, harmonizes them and then rolls them out throughout the entire company. This increases the general acceptance among the employees in the company as they recognize at least parts of their familiar processes.

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