21 CFR Part 11 Compliance in the Cloud

Posted by Rebecca Santorios on January 7, 2016

While 21 CFR Part 11 and EUDRALEX Volume 4. Annex 11 are not substantively different, there continues to be a concern that compliance to one or both is not feasible in a Cloud based environment. At ByteGrid we share no such concerns, whether you are a SaaS or PaaS provider or a Life Sciences company in need of infrastructure, our fully qualified data center and cloud solutions meet and exceed the validation provisions of both 21 CFR part 11 and Annex 11.  Our turn key Compliant Cloud offerings allow peace of mind for our customers allowing them to focus on their core business objectives. We are fully transparent and auditor friendly, now with over 50 policies, SOP’s and Form’s our Quality Management System is unique in the industry. Our client base includes CRO’s, Medical Device Manufacturers, Pharmaceutical companies, Biotech’s and SaaS providers.

While undoubtedly due for a refresh, 21 CFR Part 11 is not going away.  Any future changes are likely to encompass cloud compliance. Outsourcing to a data center that has done a 21 CFR Part 11 assessment, or touts ancillary certifications like SAS 70 Type II put’s your applications, your data and ultimately your patients at risk.
At ByteGrid, we don’t have a quality guy, we have a quality team, which extends throughout our organization, beyond our CISA, CRISC, ITIL, and PRINCE 2 experts.  Every member of our staff has a tailored training record and a keen eye for quality. Our SOP’s don’t sit on shelves gathering dust, they are enforced ever hour of every day so that when an inspector asks if our clients data center is validated the answer is always yes.

If you would like more information on 21 CFR Part 11 Hosting, contact one of knowledgeable sales specialists today by calling 855.495.0098.