Business, Data & IT
Digital Governance.
Build a robust IT compliance framework for the life sciences sector and ensure it is effective. We help you establish resilient digital governance structures—to define clear IT responsibilities and enable secure, compliant digital transformation.
What digital governance gaps are emerging in the life sciences sector?
Rapidly expanding IT environments require strict rules. Without clear governance, regulatory and operational blind spots arise:
- Responsibilities for GMP IT systems are not clearly defined: the lines between IT, QA, and business owners are blurred.
- IT system inventories are incomplete, outdated, and do not reflect actual system operations.
- There are no consistent, quality-assured change management processes for IT changes in the immediate GMP environment.
- IT risk management does not follow a standardized framework, which leads to compliance gaps during audits.
Do you know exactly which IT systems in your company are actually GMP-relevant, and who is formally responsible for them?
Our digital governance services.
We design and implement IT governance frameworks that ensure full compliance while enabling technological agility.
IT System Inventory & Criticality Assessment
Comprehensive inventory and cataloging of your IT system portfolio. Using a GAMP5-based criticality assessment, we determine which systems are GMP-relevant and what validation efforts they require. This includes defining the system ownership structure.
IT Governance Framework & Policies
Professional design of a comprehensive, practical IT governance framework. We develop your IT policy, define change control procedures for IT systems, structure incident management and access control policies, and seamlessly integrate them into your QMS.
IT Risk Management
Establishment of a structured IT risk assessment for the entire digital system landscape. We prioritize IT risks based on likelihood of occurrence and impact on GMP compliance. This includes action planning and comprehensive tracking.
Software Lifecycle Management
Systematic management of software versions, regular updates, and end-of-life systems. We develop a GMP-compliant patching strategy that includes an integrated impact assessment and handle structured sunset planning for legacy systems.
Frequently Asked Questions About Digital Governance.
What exactly is digital governance in the life sciences sector?
Digital governance encompasses the entire framework—the structures and processes—that life sciences companies use to manage their digital systems responsibly and in compliance with regulations. It clearly defines who makes decisions regarding system implementations, who bears formal compliance responsibility, and how changes to the system are implemented securely.
What is the role of an IT system owner?
The system owner is the person from the business unit who is responsible for a specific IT system. He or she bears ultimate responsibility for the system’s validation status, user acceptance, business risks, and regulatory compliance. This role must be kept separate from that of the technical system operator (the actual IT department).
How are digital governance and CSV (Computer System Validation) related?
Digital governance provides the essential foundation. It establishes the organizational structures (such as policies, defined processes, and the assignment of responsibilities) necessary for proper CSV implementation. Without effective governance, CSV activities quickly descend into chaos, become inconsistent, or cannot be sustained over the long term.
What does GRC mean in the life sciences sector?
GRC stands for Governance, Risk, and Compliance. It is an integrated management approach that combines structured IT governance, systematic risk management, and strict adherence to legal requirements. In the life sciences sector, this specifically includes GMP compliance, GDPR data protection, and cybersecurity.
Additional expertise in secure IT infrastructure.
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