Compliance services, GAMP 5, 21 CFR Part 11, ISO 13485, ISO 27001, Bioinformatics compliance, Validation packages, IQ OQ PQ, Computer system validation, Audit-ready workflows, Pharma compliance, Regulatory submissions, Data Intuitive
The platform is built so the audit trail comes for free. When you need full validation packages or submission-grade documentation, that's an Enterprise compliance engagement, scoped to your regulatory perimeter.
Audit trail and information-security controls come standard. Regulated workflows (GxP, ISO 13485 alignment, submission documentation) are delivered as Enterprise compliance services on top of that base, together with a specialised compliance partner.
Built into how the platform runs, available to every customer on credits or enterprise.
Delivered as a service, as part of an Enterprise engagement, together with our specialised compliance partner. Scoped to the standards in scope for your deployment.
Every platform run is already structurally audit-ready. An Enterprise compliance engagement turns that structure into the documentation your auditors and regulators expect. For full validation we work together with a specialised compliance partner.
A scoping call to clarify which standards apply (R&D, GxP, ISO 13485) and what evidence your auditors need.
We assemble the validation pack (IQ/OQ/PQ, change control, traceability) against your deployed configuration.
Recurring revalidation, audit support and submission response-packs as part of the ongoing engagement.