At ByteGrid the Change Management process is clearly defined. It is one of the most important elements in assuring 21 CFR Part 11 compliance of your hosted solution. Our facility is fully validated and subject to a Pharmaceutical Grade IT Change Control System.
Why a Change Management System?
Simple, it is one indicator (and a very important one) of whether or not you want to partner with a hosting company that adheres to 21 CRF Part 11. 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 your compliance concerns covered.
Our Change Management
- Change initiation
To learn more about our Quality Management System, view our Regulatory Roadmap or contact us today.
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?
For more information on IT change management, please contact us or call 855.495.0098.