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.
Success Story Maturity Assessment & Audit Preparation
Ensuring Audit Readiness
Getting a research-based pharmaceutical and biotech company ready for the FDA.
Our Capabilities
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.
Together, we develop a tailored validation strategy – from the analysis of regulatory requirements and the use of agile methods to the application of automated testing and digital validation tools.
We verify that your IT system functions as intended and meets all defined requirements. This includes documentation and execution of performance and security tests, creation of SOPs, and final validation reporting.
Regulatory requirements and IT systems continue to evolve. We support you in managing changes, conducting regular revalidations, and performing compliance checks to identify risks at an early stage.
The validation of AI-driven systems requires new approaches – especially for machine learning models and automated decision-making. We also support you in the compliant validation of SaaS, PaaS, and IaaS environments.
Migrating to SAP S/4HANA presents unique challenges for organizations. Extensive customizations and integrations make traditional validation methods resource-intensive, requiring a targeted, risk-based approach. We help you implement this efficiently and ensure long-term compliance.
MES and LIMS are essential for production and laboratory processes in regulated environments. QMS systems additionally support the centralized management of quality-related processes – from document control to CAPA management. Complex workflows and high demands on data integrity call for a focused, risk-based validation approach and deep process understanding.
Data is the backbone of modern IT systems. We ensure that your data lakes and pipelines meet the requirements for integrity, security, and traceability.
With a risk-based mindset, we help you make well-informed validation decisions and identify potential pitfalls early on.
Working together to achieve holistic and harmonized solutions
Check the integrity of your critical IT systems and validate them in accordance with international standards – customer-specific and efficient.