Increasingly complex regulatory challenges in the pharma and biotech industry are forcing companies to go paperless and adopt an end-to-end digital approach in their manufacturing process. While digital validation and automation meet very complex product lifecycle needs, they are only enablers to the intelligence at the heart of manufacturing activity.
Companies must not adopt enablers just to meet regulatory requirements but use them intelligently to move beyond, to a state of readiness and maturity that drives their manufacturing vision of the future. This is the culture that Pharma 4.0 is attempting to birth and evolve in the industry.
Some of the latest technologies augmenting validation, such as artificial intelligence, industrial Internet of Things and cold chain technology, have the potential to dramatically increase agility, efficiency, and quality in industrial production. However, it is in their intelligent deployment, from data collection to product maturity, that ValGenesis and 4Tune Engineering (4TE) are helping companies define next-generation digital manufacturing practices. Achieving the benefits of this future requires a clear vision – and ValGenesis’ recent acquisition of 4TE has accelerated that vision.
As the pioneer of 100% paperless validation technology back in 2005, and with hundreds of life sciences companies using its Validation Lifecycle Management System (VLMS) as the system of record for their validation programs, ValGenesis had been steadily expanding its product vision beyond core validation toward a holistic “manufacturing intelligence” platform.
4TE’s advanced risk management module (iRISK Platform®), used by 10 of the top 30 global life science companies, enables comprehensive risk management in the product lifecycle by making risk assessments easier, streamlining operations and improving reporting. Every product/process has associated risks. iRisk helps companies maintain compliance while also identifying inconsistencies that could be harmful to their customers. More importantly, iRisk helps support decision-making by providing an understanding of the consequences of a company’s choices. This is the kind of intelligence that is required in manufacturing, and iRisk covers all three stages in the good manufacturing practice (GMP) lifecycle.
ValGenesis’ VLMS is the industry’s first proven, 100% paperless validation lifecycle management solution, trusted by 30 of the top 50 global life science companies as the system of record for their validation programs. Covering the entire lifecycle, the ValGenesis VLMS delivers technology solutions that are validated, fully configurable and rapidly deployable through a secure private cloud. It enables new levels of collaboration, data integrity, risk management and compliance within validation lifecycle management processes. The VLMS remains the industry standard for Stage 2 validation of the GMP lifecycle.
4TE’s continuous process verification (CPV) tool (iSEE Platform™) enables real-time Stage 3 monitoring of the GMP lifecycle and supports Annual Product Quality Reviews (APQR). iSee guarantees data integrity during collection, aggregation and analysis. It can be integrated into systems, helping centralize all data required for a company’s CPV program on a single platform. iSee enables companies to check the process status anytime instead of limiting them to a picture of what happened a month or a year ago. And the reports are generated almost instantly.
With a truly synergistic product suite covering all 3 Stages of the GMP lifecycle, ValGenesis and 4TE are helping companies integrate processes more intelligently across manufacturing, creating new levels of transparency and adaptivity for a digitalized plant floor. The combined offering is the most complete “Validation Lifecycle” platform on the market delivered by a single vendor. Customers are now empowered to move from reactive to predictive and from rigid to adaptive process control for intelligent manufacturing. In addition, a newly unified development team, a more robust roadmap and an expanded services portfolio are helping ValGenesis achieve its vision of becoming the de facto Validation 4.0 standard to lead life sciences companies on their journey toward Pharma 4.0.