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|Court square group and hosting partnership solves life science cloud compliance|
|Posted: Thu Mar 02, 2017 09:50:09 AM|
March 2, 2017 — Denver, CO - Court Square Group and HOSTING have brought compliance in the cloud to a new level of ease for the Life Sciences industry. The U.S. Food and Drug (FDA) Administration’s regulations create a unique set of challenges for Life Science companies, and these solutions are designed to address these challenges in all stages of the clinical lifecycle.
FDA regulation 21CFR part 11 covers the usage and management of electronic signatures and records and requires qualified environments, validated applications, audit trails, legacy systems, copies of a retention. Court Square Group’s Audit Ready Compliance Cloud (ARCC) meets the FDA 21CFR Part 11 standards with a qualified and validated solution that extends the HOSTING world-class infrastructure into the application layer. This allows Life Science organizations to focus on the drug development lifecycle rather than the myriad of IT and regulatory challenges.
“Life Science companies can reduce time to market and focus on clinical trials, while we tackle the digital requirements with ARCC’s Qualified Hosting, Qualified and Validated Disaster Recovery and Qualified and Validated Long Term Archiving Solutions, which are all hosted in the HOSTING data centers” said Keith Parent, CEO, Court Square Group. “Multiple validated applications in a single qualified environment provide significant advantages and integration capabilities for our Life Science clients.”
“Recognizing the unique challenges facing the Life Science industry, the pairing of Court Square’s experience and Good Systems Practice (GSP) and the HOSTING industry-leading cloud technology is a natural one. Together we provide ’Compliance in a Box’, which allows Life Science companies to easily transition from Phase I to Phase II of clinical trials through the submission process.” Bill Santos, President, HOSTING.