ValGenesis, Inc., the global innovator in digital validation lifecycle management, has officially announced the launch of ValGenesis Smart GxP™, which happens to be the ever first AI-enabled platform geared towards unifying the validation and process lifecycle management processes across the life sciences industry.
According to certain reports, this particular platform arrives on the scene bearing an ability to digitally connect all stages of the product lifecycle, and therefore, provide a closed-loop feedback cycle, from process development and validation to commercial manufacturing. Leveraging intelligent automation, seamless data integration, and accelerated time to market, such an underlying setup really goes the distance to conceive unprecedented efficiency, streamlined digital tech transfer, and enhanced compliance.
Talk about the whole value proposition on a slightly deeper level, it effectively features two integrated suites i.e. Validation Lifecycle Suite and Process Lifecycle Suite.
Starting with the former, this one effectively automates commissioning, qualification, and validation (CQV) of processes, equipment, and systems, doing it all using three AI-enabled applications.
These applications include ValGenesis iVal™: which is designed to automate and streamline equipment qualification, CSA, CSV, and manufacturing systems, thus bringing forth end-to-end validation lifecycle management and ensuring greater efficiency, consistency, and compliance.
The next application in line would be ValGenesis iClean™, an application tasked with digitalizing and automating risk-based cleaning process development, validation, and ongoing monitoring to enhance compliance, efficiency, and traceability.
Another application in line here would be ValGenesis iOps™. ValGenesis iOps™ can capture real-time operational data, including equipment, cleanroom, and process logs, ensuring complete traceability and cross-site visibility.
When leveraged in conjunction, these systems can accelerate scale-up, reduce time to production, improve asset utilization, boost resource efficiency, and enable strict compliance standards.
Turning our attention towards th Process Lifecycle Suite, it arrives bearing the means to support science- and risk-based process development, achieving end-to-end quality at every possible touchpoint.
In essence, this particular suite includes the ValGenesis iCMC™ platform, which would be a purpose-built digital platform capable of streamlining CMC process development with Quality by Design (QbD) principles. Furthermore, the platform provides a structured, science-based approach to identify, quantify, and prioritize risks, all for the purpose of enabling robust control strategies and lifecycle de-risking.
Complementing this would be an integrated knowledge management facility, which ensures that risk insights and development rationales are captured and reused to drive consistency and accelerate innovation.
Beyond that, we have the ValGenesis iCPV™ solution. The stated platform promises to facilitate Continued Process Verification (CPV) through real-time monitoring. This it does while simultaneously supporting digital APQR, predictive analytics, and real-time performance insights to ensure ongoing process control and compliance.
When deployed together, the stated assortment of applications are able to reach upon a unified, scalable platform which seamlessly connects teams, systems, and data from lab to launch. The idea here is to drive end-to-end digitalization, enhanced quality, and accelerated speed across the product lifecycle.
Among other things, we ought to mention how a lot of ValGenesis Smart GxP™ is actively predicated upon VAL™, ValGenesis’ AI-powered validation assistant, who can deliver up to 80% faster document generation and reduce review cycles from weeks to hours. As for how it does that, VAL efficiency automates validation, as well as generates protocols from existing documents and enterprise data to capture results through image-based verification.
On top of that, it flags exceptions for review and analyzes content to detect gaps or GDP issues based on approved SOPs.
Anyway, coming back to Smart GxP’s knowhow, it can also work seamlessly within the broader enterprise ecosystem, integrating with systems such as LIMS, MES, ERP, and QMS to achieve end-to-end data continuity.
“ValGenesis Smart GxP represents a new generation of intelligent, connected systems,” said Dr. Siva Samy, CEO and Chief Product Strategist at ValGenesis. “By embedding AI across a unified platform that spans product and process development, validation, cleaning, and CPV, we’re enabling life sciences organizations to digitalize and streamline every stage of the lifecycle. This seamless integration eliminates data silos, accelerates tech transfer, and ensures a consistent thread of compliance and insight from lab to launch. With Smart GxP, life sciences companies can reduce risk, improve agility, and bring therapies to market faster, with confidence.”
