Govern 365 inherits the controls Microsoft 365 already supports for 21 CFR Part 11 – tenant-level access control via Entra ID, sensitivity labeling and DLP via Microsoft Purview, immutable audit logging via the Unified Audit Log, and electronic signature workflows via Adobe Sign or DocuSign integrations. Govern 365 adds the operating discipline on top: templated rooms, identity-bound permissions, structured Q&A capture, and defensible closeout. The combined posture supports the Part 11 expectations around access control, audit trail, and record integrity. You should still validate against your own Quality system and your auditor’s interpretation; Govern 365 gives you the substrate.

Yes. CROs and investigators authenticate into your tenant via Microsoft Entra ID B2B using their own organizational identity. No new accounts, no parallel password store. Trial documents are tagged with Microsoft Purview sensitivity labels that travel with the file. Access can be view-only, watermarked, time-bound, and revocable at any moment – which means a CRO that loses your contract loses the documents too, even the ones already downloaded.

Three layers. First, persistent DRM encrypts the file and binds it to a rights policy (view, edit, print, forward) that is enforced wherever the file travels. A leaked formulation sheet that lands in an unauthorized inbox will not open. Second, dynamic watermarks stamp the viewer’s identity, timestamp, and IP across every page for forensic traceability. Third, the Microsoft Unified Audit Log captures every access event – if IP appears externally, you have the evidentiary record to support response.

Yes. Capital Fundraise rooms provision in minutes from a template – folder structure, default permissions, watermark policy, and retention rules already in place. Investors authenticate via Entra B2B without you paying for a Microsoft 365 license on their side. Engagement analytics show which CMC slides, which preclinical data, and which IP filings each investor is spending the most time on – the same intel you would get from a legacy VDR, without the per-page bill.

Traditional VDRs are separate platforms with separate identity stores, separate permissions models, separate audit logs, and a separate breach surface. Every document you upload becomes a copy you no longer control, governed by a third-party DPA. Govern 365 has none of those – it uses your Microsoft tenant’s identity (Entra), classification (Purview), and audit fabric (Unified Audit Log). One platform to operate, one compliance posture to maintain, one source of truth to defend at inspection. See our Intralinks alternative, Datasite alternative, and ShareVault alternative pages.

Inside your Microsoft 365 tenant, in the geographies you have chosen at the tenant or workload level. Govern 365 does not create a parallel data store, does not move documents to vendor infrastructure, and does not require you to negotiate a separate Data Processing Agreement. The data residency you have already negotiated with Microsoft applies – which is why a sponsor running EU clinical sites can keep EMA-bound patient data inside the EU boundary while U.S. headquarters operates from a U.S. tenant region.

Every document action – create, view, edit, share, download, label change, permission change, retention disposition – is captured in the Microsoft Unified Audit Log with identity, timestamp, IP, and device context. Inspectors can be granted a scoped, read-only evidence room that holds exactly the records under inspection, with no path back to your internal R&D environment. When the inspection closes, the room closes, and the audit trail of the inspection itself is preserved.

Yes, when configured correctly. Microsoft 365 supports HIPAA, GDPR, FedRAMP, ISO 27001, SOC 2, and most country-specific patient data frameworks at the tenant level, with data residency available in dozens of geographies. Govern 365 applies the right residency, encryption, and access controls per study or per matter, so that trial data created in Germany stays in Germany, donor data in the EU stays in the EU, and the audit trail proves it. Read our HIPAA compliant file sharing guide.

Both. Pricing is flat-rate per VDR, not per page and not per user, with unlimited users on every edition. Founder Edition starts at $2,400/year for 1 active VDR – which a Seed or Series A biotech can comfortably run a capital raise on. As you scale to multiple parallel programs, multiple CROs, and multiple investor processes, editions step up to Team (5 VDRs), Growth (15), Corporate (35), and Enterprise (unlimited). See Pricing for full details.

Govern 365 is not an eCTD publishing tool – it is the collaboration and governance layer that sits between your authors, reviewers, CROs, and regulators before the eCTD package is finalized and after the regulator responds. Read more in our blog Govern 365: The Missing Layer Between Collaboration and eCTD.

Unlike legacy VDRs, there is nothing to “archive out” – the data already lives in your Microsoft 365 tenant. Closeout is a state change, not a data migration. You can (1) archive the room with read-only preservation under your retention policy, (2) export a complete trial dossier packaging every document, Q&A, and access log, or (3) dispose of the content under your Quality retention schedule with a certificate of destruction. No archive fees, no monthly extensions to keep data hosted, no CDs in the mail.

Three do most of the work. Entra ID is the identity fabric – deciding who you are and what conditions apply at every session, including for external CROs, investigators, and FDA reviewers. Purview is the information protection fabric – applying sensitivity labels, DLP, and retention policies that travel with the file. The Unified Audit Log is the evidentiary fabric – capturing every meaningful action across SharePoint, Teams, OneDrive, and Exchange, queryable per matter on demand.