iCMC™

ValGenesis iClean™ transforms cleaning validation by digitizing and automating workflows, reducing documentation cycle times, ensuring compliance, and enhancing execution efficiency, helping you bring products to market faster while maintaining the highest quality standards.

ValGenesis iCPV™ is the future of continued process verification. It continuously monitors and verifies your manufacturing processes in real time - ensuring ongoing process performance and guaranteeing the quality of your manufacturing. Automatically.

ValGenesis iOps™ transforms operational execution by providing a seamless, fully digital,and compliant solution for managing manufacturing and support activities, such as equipment, cleaning, calibration, maintenance, and quality control. It ensures data integrity, reduces human errors, and maintains ...

ValGenesis iVal™ is the leading validation lifecycle management system, delivering AI-assisted digital validation to accelerate speed to market, enhance compliance, and optimize budgets. By combining digitization with AI-driven automation, iVal streamlines qualification and validation, minimizes manua...

ValGenesis Process Lifecycle Suite enables pharmaceutical and biotech organizations to digitalize process development, scale-up, tech transfer, and continued monitoring—ensuring product quality and regulatory compliance from early development through commercial manufacturing. Built on a QbD framework, the ...

ValGenesis Validation Lifecycle Suite is the industry's leading digital solution for qualification, validation, and operations execution. It unifies iVal, iClean, and iOps into a fully digital, AI-assisted, and compliant system. This suite maximizes CAPEX value, streamlines your validation, mitigates risk,...

In this talk we explore the role of AI and ML in modernizing manufacturing, particularly in pharma and biotech. Despite the immense potential, the industry is still transitioning from traditional processes to digitalization, overcoming hurdles like regulatory compliance, cultural shifts, fulfilment of gaps in skill set and data infrastructure limitations. AI-driven analytics enhance product knowledge through its lifecycle, from process development using Quality by Design (QbD) to process validation and Continued Process Verification (CPV) in a holistic approach that ensures consistent process robustness, continuous improvement and product quality. Another example is the use of large language models applied during process validation with massive cost and time gains in generating error free validation documentation. Finally, a Case Study for an oral dosage form showcases a real-world implementation of a digital twin demonstrating AI’s role in process control, integrating real-time data analysis and predictive modelling.

Margarida Ventura (Senior Consultant) will present the webinar Revolutionizing CMC in Drug Development: How to Reduce Errors and Delays in Quality by Design on May 28 at 8:00 AM and 12:00 PM EDT.

Learn how to avoid common QbD pitfalls like inconsistent risk assessments, fragmented data, and poor collaboration. Discover digital tools and case studies that show how integrated platforms enhance CMC success.

Register to gain strategies for effective, sustainable QbD—live or on-demand via recording.

Daniel Pais (Senior Consultant) will present the webinar Reimagining Tech Transfers: How Automation and AI Assessments Deliver Smoother Processes on June 25 at 8:00 AM and 12:00 PM EDT.

Learn how AI and automation are transforming tech transfer—reducing delays, improving traceability, and enabling smarter, faster decisions. Explore strategies for digitalizing tech transfer, aligning with Pharma 4.0, and meeting regulatory expectations.

Even if you are not able to attend the live event, we still recommend registering in order to receive a link to the full recording.

Maria Batalha (Consultant) will present the webinar Redefining Compliance: Benefits of Running CPV in Real Time on July 2 at 8:00 AM and 12:00 PM EDT.

Learn how real-time CPV replaces fragmented, manual processes with integrated digital tools that enhance quality, control, and compliance. Discover how companies are using digital CPV to drive smarter decisions and align with regulatory needs.

Register to attend live or access the recording afterward.