Using Artificial Intelligence (AI) safely in highly regulated industries
In highly regulated industries such as pharmaceuticals, biotech, medtech, or the chemical industry, the use of artificial intelligence is both a challenge and an opportunity. On one hand, validating AI-based systems calls existing methods and approaches into question and poses a challenge to compliance organizations. On the other hand, AI offers tremendous potential to make validation processes faster, safer, and more efficient.
To fully leverage the potential of the technology and make compliance organizations future-proof, both technological expertise and deep regulatory knowledge are essential.
msg industry advisors support companies in tackling this challenging task and guide them in the safe and practical application of AI in regulated environments.
Our Capabilities in Validation of Artificial Intelligence (AI) Systems
AI systems – especially those based on machine learning – cannot be adequately covered by classical, static validation methods. Their ability to learn, non-deterministic nature, and constant evolution require flexible, risk-based approaches to meet regulatory requirements in the GxP environment.
msg industry advisors assist companies in validating AI systems in GxP-relevant processes – based on current guidelines such as the EU AI Act, the ISPE GAMP® Artificial Intelligence Guide, or FDA approaches to Computer Software Assurance (CSA).
Evaluation of the impact on patient safety, product quality, and data integrity
Establishment of standardized processes, role responsibilities, and monitoring mechanisms
Definition of permissible autonomy levels (e.g., "Fully Autonomous" vs. "Human-in-the-Loop")
Performance evaluation, continuous drift monitoring, and traceability
Ensuring data quality, bias detection, and data provenance
Our Capabilities in AI-Powered Validation
Cloud technologies, agile development methods, and frequent system changes are creating increasingly dynamic IT landscapes in the life sciences sector. Classical validation approaches such as the V-model or traditional GAMP methods quickly reach their limits in this context.
Artificial intelligence can help make validation processes future-proof – for example, through automated document creation, AI-supported test case generation, analysis of large datasets (e.g., audit trails), or support in making regulatory-compliant decisions.
msg industry advisors guide companies in the introduction and safe operation of AI-based applications in validation practices.
AI-supported creation, review, and maintenance of regulatory-compliant documentation
Automated generation of test cases from functional specifications
Structured risk analysis and validation strategy based on GxP principles
Evaluation of system changes with respect to validation status and compliance
AI-supported analysis and evaluation of audit results and risk profiles
Structured documentation of key system information for audit purposes
Practical training in the basics and applications of regulatory-compliant AI use
Future-proof AI – compliant, validated, trustworthy.
Make your validation practices future-ready. msg industry advisors are your consulting partners for
compliant validation of and with artificial intelligence.