Blue Mountain Quality Resources announced today that Avid Bioservices, a leading provider of integrated biomanufacturing services, has selected Blue Mountain Regulatory Asset Manager® to manage the maintenance, calibration and validation processes of their assets.
“We were looking for a proven cGMP compliant asset and process management software solution to facilitate record keeping and regulatory inspections, as part of the high quality biomanufacturing services we provide for our clients. Blue Mountain’s experience and leadership in the biotechnology industry combined with their comprehensive software products and services make them the right business partner for us,” said Nick Ferguson, Associate Director of IT, Avid Bioservices.
Avid Bioservices had previously used Blue Mountain’s Calibration Manager. They were searching for a comprehensive Enterprise Asset Management (EAM) software package that meets cGMP compliance standards, while maintaining high levels of productivity. Blue Mountain was able to meet that need with a template solution based on Blue Mountain RAM. This solution is designed with pre-configured forms, data fields and work flows, based upon industry standards, best practices and procedures which provide a quick, efficient and compliant implementation.
“The Blue Mountain template solutions and services streamlines the implementation process and reduces overall project costs dramatically” Blue Mountain President, Jim Erickson added.
Avid Bioservices plans on utilizing all aspects of the software solution, including the service event system, cGMP record keeping, and automated workflows to move its calibration, maintenance, validation and change management activities to a primarily electronic and paperless system.
About Avid Bioservices
Avid Bioservices provides a comprehensive range of high quality cGMP manufacturing services for the biotechnology and biopharmaceutical industries to support manufacturing of cGMP commercial and clinical products. With over 10 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid’s service offerings include cell banking, stability testing, clinical and commercial product manufacturing and purification, bulk packaging, final product filling and regulatory strategy and submissions support. The company also provides a variety of process development activities, including cell line optimization, process optimization and scale-up, analytical methods development and product characterization. For more information about Avid, please visit www.avidbio.com.
About Blue Mountain Quality Resources
Blue Mountain Quality Resources is the leading developer of industry standard asset management products and services—designed exclusively for the Life Sciences industry. Founded in 1989, Blue Mountain offers a complete, integrated solution from set-up to installation and from training to validation for medical device, pharmaceutical, and biotech companies of any size or scope, including multi-site enterprises. Visit www.coolblue.com for more information about our products and services.