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
IT systems in the life sciences and chemical industries are subject to regulatory requirements. The structured and documented process of Computerized Systems Validation (CSV) proves that a system functions securely and error-free by the regulations. This validation covers the entire lifecycle of a system, from the initial design to updates and decommissioning. An individual validation strategy is developed considering the specific regulatory framework conditions and the company's existing IT systems and is implemented on 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 approaches
System validation in highly regulated environments is implemented on a customer-specific basis. The key challenge is to make this validation process seamless and efficient at the same time. National laws and international best practice guidelines such as GAMP 5.2 of ISPE or comparable approaches for Computer Software Assurance (CSA) of the US FDA need to be considered. However, each company also has its existing IT architecture. Periodic reviews need to consider CSV-relevant changes such as cloud migration, ERP software upgrade or M&A activities, which are occasions for revalidation. CSV requires in-depth know-how of regulatory requirements and IT as well as tailored validation approaches.
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:
Together, we develop a validation strategy – from the analysis of individual framework conditions and system requirements to the derivation of an efficient approach, e.g. with agile approaches, to the integration of automated tests and digital validation tools.
Initial validation:
Change management & periodic review:
Decommissioning:
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.
