FAQ / Compliance
How does this fit with Microsoft Purview?
Two different layers that interoperate. Purview handles tenant-level records retention, legal hold, eDiscovery, and DLP. We handle active document governance on top — templates, approvals, review cadence, audit-log evidence. Customers run both together without conflict.
Related features
Expiration reminders
Every document carries an expiration date; the owner is reminded before it hits — review, revise, or retire, on cadence.
Archiving
Superseded and retired documents leave the active view but stay part of the permanent record — retrievable for every future audit.
Audit log
Every action, every approval, every version — captured against a named user, accessible in 30 seconds.
More in Compliance
Are you 21 CFR Part 11 validated?
No — and intentionally so. Part 11 validation sits with the customer's QA team as part of their compliance program. We provide the capabilities Part 11 audits reference (audit log, signatures, access control); your QA team runs IQ/OQ/PQ on the deployed instance.
Does the audit log meet FDA 21 CFR Part 11 requirements?
The audit log provides the capabilities §11.10(e) explicitly requires: secure, computer-generated, time-stamped, append-only, named-user attributed, captures create/modify/delete events. Whether your program meets Part 11 depends on the validation work your QA team does around it.
Can we use this for GxP-regulated workflows?
Yes — customers use the capabilities in their Part 11 and GxP compliance programs. We're not positioned as a validated QMS platform (MasterControl and equivalents fill that slot). For SOPs and documented information in GxP scope where the customer's QA team runs validation, we fit well.
Question not on this list?
A 30-minute assessment is usually the fastest way to get a specific answer to a specific question about your organization's profile.