ValGenesis provides enterprise validation lifecycle management systems, with Process Manager joining its suite of software designed to make the production process for pharmaceuticals more efficient.
Process Manager was created to eliminate commonly cited mistakes that regulatory agencies observe in the cleaning validation program, ValGenesis states. It manages this by digitizing, automating, and controlling the end-to-end cleaning validating lifecycle, geared towards the US Food and Drug Administration (FDA)’s requirements for cleaning validation.
ValGenesis outlined that the common issues often found in regulatory inspection of the cleaning validation process involve the failure to validate the cleaning process of equipment and facilities, an inadequate sampling plan, inadequate acceptance criteria, and lack of justification for worst-case assessment, amongst other problems.
By adopting Process Manager, ValGenesis’ clients can replace the paperwork around cleaning validation, as well as receiving a dynamic impact assessment of any change to the cleaning validation program for product, process, and equipment.
The software also provides identification of sampling locations through 2D and 3D equipment images, and automation assessment of worst-case product and worst-case equipment.
ValGenesis added that Process Manager enables risk assessment at each contact part level to combat cross-contamination and improve product safety.
According to Siva Samy, CEO of ValGenesis, the company’s software is used by over 30 of the top 50 global life science companies for validation lifecycle management system. The list of companies using the company’s software includes Alexion, a subsidiary of AstraZeneca, Bayer, Biocon, and Roche.
“Our purpose-built cleaning validation solution emphasizes critical thinking upfront, helping life sciences companies build a risk-based approach and culture of quality in line with the most stringent regulatory requirements. In fact, two of the top 10 global life sciences companies have started implementing our groundbreaking cleaning validation solution,” added Samy.
Samy noted that the digitization of validation process is a ‘key enabler’ of Pharma 4.0, with the software able to collect data, conduct analysis, and perform reporting. The software also contains an automated documentation system with configurable templates for cleaning validation master plans, standard operating procedures, cleaning tests, and validation protocols.
Alongside Process Manager, ValGenesis offers software for managing validation lifecycles, risk management, electronic logbooks, and process insight. The company also possesses a consulting business to partner with pharma companies to help develop and manage the product and process lifecycle.
