Accelerating Compliance Through Data Digitalization and AI

AI-powered validation is transforming the life sciences industry by eliminating manual bottlenecks and accelerating progress. Instead of relying on slow, error-prone human checks, organizations can now leverage intelligent automation to ensure accuracy, consistency and compliance — while freeing experts to focus on high-impact innovation.

Manual validation has long burdened computer system validation (CSV), commissioning, qualification and validation (CQV), and computer software assurance (CSA) processes with delays, high costs and fragmented workflows. As systems and data become increasingly complex — spanning digital quality and validation systems, as well as regulatory expectations — traditional validation approaches can’t keep up, leading to compliance risks and slowing time-to-market.

Artificial intelligence offers a breakthrough: machine learning models can detect anomalies, flag inconsistencies and mitigate risks before they escalate. Natural language processing empowers systems to interpret regulatory guidelines and align documentation with evolving frameworks such as the FDA’s CSA approach and the International Society for Pharmaceutical Engineering’s Good Automated Manufacturing Practice (ISPE GAMP 5, Second Edition). The result is stronger data integrity, audit readiness and streamlined operations — all while enabling scientific and quality experts to focus on innovation.

Register for this webinar to learn how data digitalization and AI-powered validation can reduce risk, improve efficiency and turn compliance into a competitive advantage.

Speaker

Emmanuel Cansino, Senior Director Industry Solutions, ValGenesis

Emmanuel has been with ValGenesis for 19 years and has been involved in many areas of the company, including product development, project management and customer support. He currently leads the solution engineering team.

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