New partnership offers cost-effective paperless validation to GMP – governed organisations in Australia.
PharmOut, the Asia Pacific’s leading Pharmaceutical consulting organization, has announced a strategic partnership with ValGenesis Inc, a pioneer in paperless validation software systems.
Pharmaceutical, medical device and other GMP-compliant industries incur considerable costs in creating, maintaining and storing the mountain of paper-based documents required for the routine operation of their manufacturing facilities. Australian companies have also long struggled with a shortage of experienced validation professionals, further adding to their costs.
This new partnership offers a cost-effective and innovative validation solution to Australian companies. Combining the expertise of PharmOut’s large team of validation consultants with the ValGenesis Validation Lifecycle Management System, will deliver faster, cheaper validation services in Australia. It will also deliver all the advantages a paperless system offers, making Australian manufacturers more competitive in global markets.
PharmOut’s founder, Trevor Schoerie said: “As the largest provider of outsourced validation services in the Asia Pacific region, our customers were asking us for ways they could slash both the cost and time required to meet their validation obligations. We evaluated the available software solutions and found that ValGenesis was the stand-out product. We realised that we could train our consultants to become experts in the ValGenesis software, allowing us to fast track the delivery of validation services, whilst also providing all the benefits of a paperless validation solution to our customers.”
“By allowing life science companies to manage their validation processes electronically, the ValGenesis Validation Lifecycle Management System (VLMS) significantly reduces the validation cycle time and cost, eliminates potential data integrity issues in the validation process, enables standardization and enforces consistency and compliance in the corporate validation process.” said Robert van der Laan, Vice President of Professional Services at ValGenesis. “ValGenesis VLMS has been implemented by 10 out of the top 20 global life science companies. We seek to align our product roadmap with the evolving regulatory landscape to help our clients to enable and enforce regulatory compliance. We are confident our partnership with PharmOut will help the ValGenesis VLMS system become the de-facto standard for paperless validation across the life science companies based in Australia and New Zealand.”
PharmOut looks forward to working with ValGenesis into the future and supporting their expansion into Australia.
PharmOut is an international consultancy founded in 2006 which has grown a strong reputation in offering leading GMP compliance, validation, regulatory, engineering and architectural consulting services solutions to the pharmaceutical and life science industries.
PharmOut holds ISO 9001:2015 certification from LQRA and our Quality Management System is certified to the ISO 9001:2015 standard for the provision of engineering, architectural design and consultancy services.
ValGenesis, Inc. is the creator of an innovative software platform serving as the foundation for managing compliance-based validation activities in Life Sciences companies. ValGenesis, Inc. provides the first enterprise application to manage the corporate validation lifecycle process. As the only system for managing validation execution and approval 100% electronically, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award. The solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. For more information, visit ValGenesis’website at https://www.valgenesis.com