Computerized Systems Validation
Protect critical IT architecture, establish secure processes and ensure data integrity by validating your IT systems. We are your consulting partner for complex requirements in regulated companies.
Efficient validation of IT systems: Focus on security & compliance
In the life sciences and chemical industries, IT systems are subject to regulatory requirements. The structured and documented process of Computerized Systems Validation (CSV) demonstrates that a system operates safely and without errors. Validation spans the entire lifecycle of a system – from initial concept through updates to decommissioning. An individual validation strategy is developed based on the specific regulatory framework and the company's existing IT systems, and implemented at the process and tool levels.
msg industry advisors support you with in-depth regulatory expertise and specialized IT know-how in the validation of computer systems in accordance with international best practices.
Complex regulation requires tailored validation approaches
Each company operates with a unique IT landscape – ranging from traditional on-premise systems to cloud-based and AI-driven applications. At the same time, national laws and international best practices such as GAMP 5.2 or the FDA’s CSA must be taken into account. Periodic reviews must ensure that CSV-relevant changes – such as cloud migrations, ERP software upgrades, or M&A activities – are executed smoothly and remain compliant. Our focus is on designing validation processes that are seamless, efficient, and future-proof.
Working together to achieve holistic and harmonized solutions
msg industry advisors support you in the professional design and implementation of internal validation of your IT systems – for an efficient and sustainable implementation in your company.
Our services include:
Validation Strategy:
Initial Validation & Implementation:
Change Management & Periodic Review:
AI & Cloud Validation:
S/4HANA Validation:
Validation of MES, LIMS, and QMS Systems:
Validation of Data Lakes & Pipelines:
Critical Thinking in Validation:
Check the integrity of your critical IT systems and validate
them in accordance with international standards – customer-specific and efficient.
Further expertise on Compliance, Validation & Risk
Medical Device Compliance
Accelerate time to market and increase product quality and customer satisfaction with seamlessly integrated, optimized compliance processes.
Business Continuity Management
Increase the resilience of your company and implement Business Continuity Management tailored to your requirements to ensure the operational security of critical processes.
Information Security Management
Protect yourself against cyber-attacks and data leaks and work with us to establish internationally recognized standards for information security.
