Cloud Hosting and 21 CFR Part 11 Compliance

Posted by Rebecca Santorios on January 7, 2016

The Issue

Traditionally, Part 11 regulated companies have not used third party providers to host applications and data because it was believed that they could not meet privacy laws, security concerns, audit transparency requirements and they simply did not operate an adequate quality system with documented policies and procedures to satisfy compliance for 21 CFR part 11 hosting. This is still true of the majority of datacenters in the marketplace so vendor selection is very important to successful outsourcing.

Questions to ask a potential vendor who offers 21 CFR Part 11 Hosting:

  • Will you implement a service level agreement?
  • How do you handle Installation qualification?
  • How do you handle change control?
  • Do you have a standard set of SOP's and can I view these?
  • How do you handle encryption?
  • How do you handle disaster recovery?
  • How do you handle an inspection or audit?

The answers to these questions will give you insights into whether or not you want to partner with a company for 21 CFR Part 11 hosting. And 'partner' is key here - since this company will be responsible for an integral part of your company's operations you certainly want to be able to trust that they have you covered. Can they do a better job than you can at a reduced price? Because outsourcing in the first place should save you money on both IT staff and infrastructure cost.

The Solution

ByteGrid has invested heavily to ensure that we offer one of the most robust Quality Systems for any company looking for 21 CFR Part 11 hosting. Our quality system is comprised of over 40 compliance policies, standard operating procedures and forms. All of the hardware (server, switches etc.) used in the design of the 'BioCloud' have been fully validated and like our facility are subject to a Pharmaceutical Grade IT Change Control System. Further, every ByteGrid employee has a customized training schedule based on their job function. We have been independently audited by many Pharmaceutical and Health Care companies in the past few years, and always have our regulatory staff on hand to walk any potential client through our documentation and the initial validation of our infrastructure and the systems we now have in place.

To learn more about our 21 CFR Part 11 Compliant Hosting solution contact one of our specialists today at 855.495.0098.