Court Square Group, a professional consulting firm and leading managed service provider offering services in information technology, business process management, life sciences quality and compliance, will be providing the cloud hosting services. The Court Square Group qualified cloud infrastructure is fully 21 CFR Part 11 compliant as relates to system components, and hosts numerous validated applications.
As part of the offering, customers will receive a Validation Package with individual tailoring by USDM, a leading global professional services firm focused exclusively on providing business process, technology and compliance solutions for the regulated life science industry.
Generis will configure their CARA software, which is the leading industry User Interface and business rules configuration engine, to provide specific applications for Life Sciences, including Submissions (with publishing integrations)
"USDM Life Sciences is very excited about Generis’ new cloud based subscription offering ,” said Gerald O’Driscoll, Vice President of ECM Solutions and Services at USDM Life Sciences. “Generis CARA combined with USDM’s life sciences compliance and implementation experience will allow our clients to rapidly deploy this next generation based content management solution.”
Keith Parent, CEO of Court Square Group says “The Generis CARA product hosted in our fully qualified cloud environment is a great example of the next wave of world class applications available to the Life Science Industry. As you embrace the cloud model you need a hosting partner that understands 21 CFR Part 11 requirements and hosting validated applications on qualified infrastructure, this is the key to maintaining your regulatory compliance.”
“The opportunity to work with USDM and Court Square Group to leverage their expertise in both cloud content management in specific Life Sciences applications and validation is of key importance to us”, said James Kelleher, CEO of Generis. “This allows us to add a flexible cloud-based offering of CARA to our existing product portfolio to support existing and new customer demands.”
About Court Square Group
Court Square Group was founded by Keith Parent, its sole shareholder, in 1995. Court Square has deep expertise in systems specific to the preclinical and clinical phases of drug development including but not limited to LIMS systems, eLab notebooks, Clinical Trial Management Systems (CTMS) ,EDMS (electronic Document Management Systems), eCTD (electronic common technical documents) and electronic submission systems to the FDA (esub). Court Square understands the distinct needs of this highly regulated industry by leveraging its Life Science & Quality practice to work directly with its IT practice to stay versed in the regulatory and compliance requirements of the existing and growing client base.
535 Chapala St., Santa Barbara, CA 93101