What are recent developments?

We elevated our Validation Lifecycle Management System (VLMS) by integrating AI and machine learning, significantly reducing validation cycle times and costs. Our refined risk-based approach aligns seamlessly with evolving global regulatory expectations. 

Can you describe the three AI bots ValGenesis will release to market in 2025?

Bot One streamlines protocol generation by digitalizing the validation process, eliminating manual tasks, and reducing effort up to 50%. Our intelligent scoring system automatically identifies the closest match for equipment, documents and content to auto-generate protocols. While traditional protocol generation takes two or three weeks, our bot completes it in just five to eight minutes, reducing effort by up to 80% while significantly improving content accuracy.

Bot Two optimizes validation execution by transitioning from paper-based to digital validation, cutting execution time by up to 50%. Using AI, the bot analyzes evidence, compares expected results, and auto-populates actual results, reducing the process from 15 minutes to just one minute. It ensures a Right First Time (RFT) approach, minimizing rework, discrepancies, and audit risks while enhancing quality, efficiency and regulatory confidence.

Bot Three focuses on review by exception, automatically parsing evidence at every step and comparing actual versus expected results. Any misalignment is flagged for action, allowing users to focus only on exceptions, reducing review and approval cycles from weeks to hours. These innovations can help companies lower validation budgets by at least 50%, translating into savings of hundreds of millions of dollars. With the launch of VLMS 5.0, we introduce the industry's first AI-powered digital validation platform. 

What case studies illustrate ValGenesis competitive advantage?

NEXA uses our VLMS tool to enhance their equipment qualification processes and saved 1,500 hours in documentation efforts compared to paper-based methods. Project completion time decreased by four days. 

Merck Millipore faced challenges in standardizing validation across global operations while maintaining regulatory compliance. With ValGenesis VLMS, they achieved a significant reduction in validation cycle time through automation and streamlined workflows, eliminated paper-based processes, and improved inspection outcomes.

Companies typically allocate 30% of their total costs to validation, and we are working to reduce this by at least 50%. 

What challenges does the industry face as it moves towards digitalization?

Adopting digital solutions requires alignment with evolving regulatory expectations, as companies must ensure data integrity, auditability and risk-based validation. Many organizations rely on paper-based, manual systems. Transitioning to digital validation requires a cultural shift, user training and strong leadership buy-in. Seamless connectivity between QMS, MES, LIMS, ERP with digital validation platforms is essential but can be challenging due to disparate data sources and outdated infrastructure. Robust cybersecurity measures are needed to protect data, cloud environments and electronic records from breaches or manipulation. Ensuring that AI models remain trustworthy, explainable and validated within regulated environments is an ongoing focus.

We address these challenges by offering risk-based, AI-powered validation solutions that enhance compliance, efficiency, and seamless integration.

How are pharma/biotech companies integrating AI into validation workflows?

Pharma and biotech companies are rapidly integrating AI into their drug development and manufacturing workflows to enhance efficiency and data-driven decision-making. AI models analyze historical process data to predict deviations, optimize parameters, and ensure real-time process control for continuous manufacturing and CPV. AI-driven risk assessments enable companies to prioritize validation activities based on impact and compliance risk, aligning with evolving CSA (Computer Software Assurance) guidelines. AI enables organizations to stay proactive and compliant by scanning and analyzing regulatory updates and industry trends in real time.

What are ValGenesis’ primary objectives and market expansion strategies for 2025?

ValGenesis is committed to accelerating digital transformation in drug product development, validation, and Continuous Process Verification (CPV) through AI-driven innovation, global expansion, and strategic industry partnerships within the Smart GMP platform. We will enhance our Quality by Design system to meet evolving CMC requirements, ensuring robust process control. Our platform will integrate AI and ML more deeply to reduce validation cycle times, increase efficiency, and improve compliance. We will strengthen our CPV capabilities to provide real-time process monitoring and insights, enabling continuous process optimization and regulatory adherence.