QFINITY · Projects · Project News
A look inside our project work.
An overview of the projects QFINITY takes on for its clients - a look at how we work and at the projects we have already delivered in the GxP-regulated environment.
Current projects
Enabling GxP-Compliant Cloud Services through Global QMS Enhancement
A CDMO wanted to use cloud services – including hosting GxP-relevant systems. QFINITY evolved the global quality management system so that Infrastructure as a Service, Infrastructure as Code, and cloud operation and monitoring are covered in a fully GxP-compliant way – on time and on budget.
Problem Statement
The customer is an international contract development and manufacturing organization (CDMO) in the pharmaceutical industry. Its services span comprehensive product development, from the early research phase through commercial-scale production. It also manufactures active pharmaceutical ingredients and finished medicinal products.
The company plans to expand its use of cloud services, particularly for infrastructure (IaC), and later use them to host GxP-relevant systems. To achieve this, the customer needed:
Project Execution
In the first phase, QFINITY analyzed the company’s existing quality management system for its suitability for cloud services and evaluated it against regulatory requirements and relevant industry standards. QFINITY then developed concrete change proposals for the affected processes and aligned them with the responsible departments. The customer approved the finalized documents in accordance with its own processes and implemented them within the company.
Results and Benefits
The project was completed successfully, on schedule and within the planned budget. This was possible because the analysis, creation, and approval activities were properly planned and precisely coordinated.
The revised processes of the global quality management system provide a clear, regulatory-compliant framework for the use of cloud services. In particular, they cover Infrastructure as a Service (IaaS), Infrastructure as Code (IaC), and the deployment and operation of computerized systems in cloud environments. They also define consistent requirements for planning, qualification, change and release management, monitoring, and incident and problem management in cloud contexts. These requirements ensure that all activities are documented consistently in a GxP-compliant manner.
IT Quality Management for Secure System Restoration: Recovery from Ransomeware attack in GxP-Regulated Environments
After a ransomware attack, a drug-discovery company had to recover GxP-relevant systems and data – fully documented. QFINITY guided the recovery from an IT quality management perspective: from forensically grounded quality planning through integrity-assured data migration to validated release.
Problem statement
The client is an international company in pharmaceutical active ingredient research. Its services include researching and developing new active ingredients and building software platforms for specialized methods in this environment. The company became the target of a ransomware attack that encrypted large parts of its infrastructure, systems, and data, making them inaccessible. Because some of these data and systems were GxP-relevant, the restoration of IT services and functions had to be closely overseen – and fully documented from an IT quality management perspective.
To achieve this objective, the client required:
Project execution
At the start of the project, QFINITY recorded the recovery activities defined by the project team and evaluated their regulatory relevance. The results of the forensic analysis of the ransomware attack fed into this work, serving to review the effectiveness of existing quality management processes and optimize them where necessary. Based on this analysis, QFINITY developed a quality plan covering the following activities and areas:
Implementing this plan and the associated activities required intensive coordination with all departments to enable a fast, secure release of IT services and systems in full regulatory compliance.
Results and benefits
The project was completed successfully on schedule and within the planned budget because analysis, documentation, and release activities were appropriately scaled and efficiently coordinated. The restored IT systems and associated data fully meet all internal and regulatory requirements. Throughout the recovery, internal quality assurance continuously monitored the documentation in close coordination with the IT quality function, ensuring complete regulatory compliance and adherence to the highest internal quality standards. The resulting IT infrastructure meets the most stringent requirements for security, data integrity, and operational reliability.
Global QMS concept for an international pharmaceutical company: design and implementation
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:
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:
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.
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.
For more information about QFINITY’s case studies, check out our Project News.