Shaping the regulated quality of tomorrow.

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:

• Support in documenting and evaluating recovery activities for infrastructure, IT systems, and data
• Coordination of activities with other departments, e.g. IT Security, Data Privacy, and IT Operations
• Creation of quality reports for individual sub-areas of restored IT services and functionalities
• Review and, if necessary, improvement of existing quality management processes to prevent future IT security risks

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:

• Development of a procedural recovery framework by integrating forensic findings with the existing quality management framework
• Restoration of a secure IT infrastructure by establishing a secure environment
• Creation of regulatory documentation by fully documenting the restored IT infrastructure for compliance requirements
• Reinstallation of IT systems as clean new installations to eliminate malicious code
• Integrity-assured data migration through documented transfer of relevant data while maintaining consistency
• Consolidation of data sets by synchronizing restored data with information newly generated since the attack
• Comprehensive system validation through documented testing of restored systems and data prior to release
• Timely quality reporting and release management for efficient approval of infrastructure and systems

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.

In recovery, what matters is not speed but the complete traceability of every recovery activity.

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.