Many FDA regulated companies follow GAMP 5 for computer systems validation. ByteGrid offers companies the fast track to a fully validated, compliant cloud system that fits perfectly with their organization's existing validation approach.
GAMP 5 Essentials for Cloud Providers
Under GAMP 5, the use of cloud technology will first need to be analyzed as part of the system risk assessment, which drives the remaining validation activities. An experienced cloud hosting provider can help you prepare one. Cloud service providers must be addressed under the company's supplier quality program, and the full system, including the provider's infrastructure, will need to be qualified. Validation documentation will, of course, need to be consistent with FDA requirements.
When dealing with hosting providers that aren't prepared to meet cGMP requirements, regulated companies may find themselves trying to find 'creative' ways to cover some of the obvious compliance gaps that they face, or searching for resources to carry out these tasks themselves.
Compliant cloud hosting, on the other hand, snaps in to your computer system validation package with qualification documentation prepared to agency standards, in a format that's readily understood by auditors and the regulated company's quality unit.
GxP Compliant Cloud Hosting Checklist
Make sure your provider can offer the following:
- Established Quality Management System
- Documented, up-to-date procedures (SOPs)
- Current training records for all staff
- System Risk Assessment
- Fully validated infrastructure
- GxP experience
- Backup and disaster recovery
ByteGrid has a full time compliance staff with decades of experience successfully validating computer systems. We work with our clients to ensure that when we host their application, there are no compliance gaps. Our infrastructure is fully qualified specifically to meet FDA requirements – we don't have to reverse engineer our systems to satisfy GMP regulations. We offer truly compliant cloud hosting – and the full set of services to support regulatory compliance throughout your system's life cycle.
Contact us today to get started with GxP compliant cloud hosting.