Quality Assurance of AI Systems in the Pharmaceutical Industry

Expert Article

Quality Assurance of AI Systems in the Pharmaceutical Industry

AI developers, particularly in the pharmaceutical field, face high demands for quality assurance.

External IT systems, such as add-ons for artificial intelligence, must be legally validated before being used in pharmaceutical production. This is in the best interest of pharmaceutical companies, as they are ultimately accountable for their suppliers.

17. October. 2024

Karin Schnedlitz

Content Managerin

Challenge

Strict regulations apply not only in production

Product safety holds a particularly high priority in the pharmaceutical industry. Companies must guarantee that they manufacture, test, and store medications in compliance with all legal regulations. This is ensured through the internationally recognized “GxP”-regulations.

However, risks can also arise in connection with outsourcing services. For example, if a pharmaceutical company wants to integrate external AI systems into its internal software, it must first evaluate the AI provider for suitability and reliability.

Becoming a GxP-Validated Supplier

The “Good Automated Manufacturing Practice”(GAMP)-guide (currently: Version 5) is the standard for validating GxP-compliant, computer-based systems in the pharmaceutical industry. An AI company must demonstrate that its systems meet these requirements through quality-assured software development. Leftshift One recently developed a comprehensive Quality Management System (QMS) based on GAMP5, with additional alignment to the ISO-Standard 9001, for a well-known pharmaceutical manufacturer.

In this case, it was the optimal solution to meet the strict regulations. The completed QMS now documents all general and project-specific information necessary to operate software in a pharmaceutical environment.

A supplier validation by the pharmaceutical manufacturer—similar to an audit—evaluated the QMS. Leftshift One successfully passed this validation and is now a qualified supplier for the mentioned pharmaceutical company.

Experience & Potential

The validation taught us at Leftshift One, in our role as an AI service provider, a great deal about our own internal processes. By systematically structuring them in the QMS, we also laid the foundation for an upcoming ISO 9001 certification, which will take place in the near future. Read the editorial on AI-powered quality assurance, gain insight into the benefits of a QMS, and familiarize yourself with our solution for Predictive Quality.

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