Shaping the regulated quality of tomorrow.

Grown through acquisitions, an international pharmaceutical company needed a harmonized global QMS. QFINITY designed and implemented it along GAMP 5 and ITIL – across infrastructure, software development, and computerized system validation – including a training concept and a worldwide rollout.

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 international company in pharmaceutical active ingredient research. Its services range from researching and developing new pharmaceutical compounds to building software platforms for specialized methods in this domain.

After years of significant growth through acquisitions, the company needed to consolidate its 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 Infrastructure, Software Development, and 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, QFINITY analyzed the organization’s existing quality management systems and evaluated them against regulatory requirements and industry standards.

QFINITY then developed a new QMS concept 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
  • Project Phase
    • Validation and Implementation of GxP-regulated systems
    • Implementation of non-regulated systems
  • Operational Phase
  • Retirement Phase
  • Data Migration
  • Data Archiving

As part of the implementation, QFINITY developed all necessary policies, directives, SOPs, work instructions, and document templates. It also created training materials for all relevant areas and planned and ran training sessions for the respective employee groups and departments.

A global QMS thrives not on the rule book but on a shared understanding of quality across every site.

Results and Benefits

The project was completed successfully on time and within the planned budget. Appropriately scaling the analysis, development, and rollout activities – and coordinating them efficiently – made this possible. Potential bottlenecks were identified early and avoided, keeping the overall project timeline on track.

The implemented global QMS significantly improved both efficiency and compliance. Globally harmonized processes and approaches ensured consistent compliance with regulatory requirements across the entire organization. Process efficiency increased substantially, and the company established a unified global understanding of quality.

The company’s internal quality assurance function reviewed the QMS approach and related documentation, and any inconsistencies identified were resolved promptly before rollout.

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