Global QMS concept for an international pharmaceutical company: design and implementation
This case study focuses on the design and implementation of a global QMS concept for an international pharmaceutical company.
Problem Statement
The client is an internationally operating company in the field of pharmaceutical active ingredient research. Its services include the research and development of new pharmaceutical compounds as well as the development of software platforms for specialized methods in this domain.
Due to significant growth through acquisitions in the past, it became necessary to consolidate the various quality management approaches into a harmonized global Quality Management System (QMS).
To achieve this objective, the client required:
- Development of a global QMS concept that integrates the requirements of existing QMS with relevant standards such as GAMP and ITIL while ensuring regulatory compliance
- Evaluation of existing inconsistencies and development of appropriate solutions
- Creation of policies, directives, SOPs, work instructions, and required templates for the areas of: Infrastructure, Software Development, Computerized System Validation based on the developed QMS concept
- Development of a training concept and training materials for the global QMS rollout
- Execution of global QMS training sessions for relevant departments and stakeholders
Project Execution
In the initial phase, the existing quality management systems within the organization were analyzed and evaluated against regulatory requirements and industry standards.
Subsequently, a new QMS concept was developed, covering the following areas:
- Infrastructure
- IT Risk Management
- IT Asset and Inventory Management
- Monitoring and Capacity Management
- Data Centre / Server Room Management
- Infrastructure Qualification
- Backup and Restore Management
- Change and Patch Management
- Service Request Management
- (Major) Incident Management
- Problem Management
- Software Development
- Software Development Planning
- Software Requirements and Risk Assessment
- Software Design and Architecture
- Software Development
- Software Quality Assurance
- Software Release and Maintenance
- Computerized System Validation
As part of the implementation, all necessary policies, directives, SOPs, work instructions, and document templates were developed. Additionally, Training materials were created for all relevant areas and Training sessions were planned and conducted for the respective employee groups and departments.
Results and Benefits
The project was successfully completed on time and within the planned budget. This was achieved through appropriate scaling of the analysis, development, and rollout activities, which were efficiently aligned and executed in a resource-efficient manner. As a result, potential bottlenecks were identified early and avoided, ensuring a smooth overall project timeline.
The implemented global QMS significantly improved both efficiency and compliance. The globally harmonized processes and approaches ensured consistent compliance with regulatory requirements across the entire organization. Process efficiency was substantially increased, and a unified global understanding of quality was established.
The QMS approach and related documentation were reviewed by the company’s internal quality assurance function, and any identified inconsistencies were promptly resolved prior to rollout.
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