Trust & Compliance
Orbit is validated software for regulated pharmacovigilance work. Here's how we support your GxP obligations, and what we can share with your QA team.
Built for GxP environments.
GxP validation
Orbit is developed and validated following GAMP 5, the industry's risk-based approach to computerized system validation.
Validation package
We provide a validation package to customers to support your own computerized system validation and reduce the effort needed to bring Orbit into a GxP environment.
21 CFR Part 11 and EU Annex 11
Orbit is built to support the requirements for electronic records and signatures, including audit trails, electronic signatures, and access controls. Our Part 11 and Annex 11 assessment maps each requirement to Orbit's controls and is available on request.
SOC 2 Type II
Our security, availability and confidentiality controls are independently audited under SOC 2 Type II. The report is available on request.
Hosted on AWS
Orbit is hosted on Amazon Web Services (AWS), so it runs on infrastructure that carries its own independent security and compliance certifications.
Shared responsibility
Validation is a partnership. Orbit covers the software and our hosted environment; your team remains responsible for validating Orbit for your intended use, your configuration, and your own procedures. The validation package is designed to make that work faster.
Request documents
Request our SOC 2 Type II report, Part 11 / Annex 11 assessment, or validation package. Our compliance team will follow up with you.
Thanks for your interest!
Thank you. Our compliance team will be in touch shortly.
