Announcement posted by PharmOut Pty Ltd 02 May 2018
ValGenesis and PharmOut Announce a Partnership Founded on a Paperless Validation Initiative.
New partnership offers cost-effective paperless validation to GMP-governed organisations in Australia
Cost-effective
paperless validation now available to Australian GMP-governed organisations
with announcement of new partnership
Melbourne,
Australia, April 27 2018.
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 industries that must be compliant with Good
Manufacturing Practice (GMP) incur considerable costs in creating, maintaining
and storing the mountain of paper 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 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” he said.
PharmOut looks
forward to working with ValGenesis into the future and supporting their
expansion into Australia.
You can find
out more about each company and the solutions they provide on the ValGenesis and PharmOut websites.
About PharmOut
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.
About ValGenesis
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 http://www.valgenesis.com