Last updated: 2026-11-06
These terms ("Terms") govern your use of Regscribe ("Regscribe", "we", "us"), an AI-assisted tool that checks documents against regulatory and quality-standard frameworks for pharma/biotech companies. By using Regscribe, you agree to these Terms.
About these terms: Regscribe is currently operated as a working name, ahead of formal company incorporation — see our Privacy Notice for detail on that. These Terms are written to be accurate and publishable now, on that basis. Governing law/jurisdiction below is a placeholder pending that decision.
What Regscribe is — and isn't
Regscribe reads a document you upload and produces an AI-generated readiness assessment against a regulation or standard you select (e.g. 21 CFR Part 11, EU GMP/GDP, ISO 27001), from a knowledge base of regulatory and quality-standard frameworks. This is a tool to help you find gaps before a real audit — it is not a substitute for your own quality system, validation activities, or regulatory judgment.
Regscribe also includes three related tools: an SOP overlap & consolidation feature that reads a set of your SOPs against a selected framework and flags gaps and consolidation candidates where documents overlap; Regscribe AI Governance, a separate module for assessing third-party AI tools your organisation is considering acquiring against AI-governance and data-protection requirements (e.g. EU AI Act, HIPAA); and New System, a guided drafting tool that helps you build a GAMP5/DPIA validation document set (DPIA, URS, Risk Assessment, VMP, IQ/OQ/PQ, Traceability Matrix, VSR) for a new system you're standing up, from your own typed answers — unlike the other tools, New System doesn't call Anthropic's API at all. All three are advisory in the same way as the core document check described below, and are subject to these Terms.
- Regscribe's output is advisory. A "ready to publish" verdict is an AI-generated assessment, not a guarantee that a document will pass a real regulatory inspection or audit.
- You remain solely responsible for your organisation's compliance with any regulation, standard, or quality system requirement that applies to you — including any validation of your own computerised systems, review of your own documents by qualified personnel, and final regulatory decisions.
- Regscribe does not perform, and this tool is not, a substitute for a validated quality management system, an independent audit, or professional regulatory/legal advice.
Your account and acceptable use
- You must sign in via single sign-on to use Regscribe's tools — currently Microsoft Entra ID; Google and Okta are built in and available where configured for your organisation, but Microsoft is the only provider live today. You're responsible for keeping that sign-in secure; Regscribe never sees or stores your password (see our Security Policy).
- You agree not to use Regscribe to upload documents you don't have the right to share, to attempt to disrupt or overload the service, or to attempt to reverse-engineer or extract the underlying prompts/models Regscribe uses.
- Updated 2026-08-01: Regscribe is currently invite-only — access requires both a valid sign-in and prior authorisation on an internal allowlist; it is no longer open to anyone who can sign in with an eligible account. Regscribe still has no per-organisation access controls (no org-level tenancy/RBAC), and access is subject to the rate limits described below.
Your content
- You own the documents you upload and the output Regscribe generates from them. Regscribe claims no ownership over either.
- As described in our Privacy Notice, document content is sent to Anthropic's Claude API to generate your analysis, then discarded — Regscribe does not retain your documents or full analysis results after your session ends. (Regscribe does retain a small amount of summary-level audit-trail metadata about the analysis — see the Privacy Notice for exactly what.)
- You're responsible for having the right to upload any document you submit, including where it contains other people's personal data (e.g. signatories or approvers named in a signature block).
- Regscribe is not designed for, and does not knowingly accept, documents containing patient-identifiable health information (PHI) or other personal data of an identifiable individual (PII) — for example, an ICSR case narrative that names or otherwise identifies a specific patient, or a home address, personal phone number, national ID, or bank account number appearing in a document. This applies across all rubrics — it's most relevant to PHI for the GVP rubric, which is intended for checking pharmacovigilance documentation and process compliance rather than real patient-identifiable case data, and most relevant to PII for frameworks like NIS2 and KRITIS-Dachgesetz, where resilience and personnel-security documents can plausibly carry employee personal data. If you hold genuine PHI or PII you need assessed, redact the identifying details before upload or contact us first at the address below.
No warranty
Regscribe is provided "as is" and "as available," without warranties of any kind, express or implied, including any warranty that the service will be uninterrupted, error-free, or that its output will be accurate, complete, or fit for any particular regulatory purpose. AI-generated analysis can be wrong — always verify findings against the source document and your own regulatory expertise before relying on them.
Limitation of liability
To the fullest extent permitted by law, Regscribe and its founder will not be liable for any indirect, incidental, or consequential damages arising from your use of the service, including any regulatory finding, audit outcome, or business decision made in reliance on Regscribe's output. Regscribe is currently offered free of charge; our total liability for any claim arising from these Terms is limited to the greater of £0 and any fees you've actually paid us in the 12 months before the claim arose.
Availability
Regscribe is live and in active use, currently in early access, and has not undergone formal GAMP 5 validation. We don't currently commit to any uptime or availability guarantee (no SLA). Rate limits apply to the document-analysis endpoints to manage cost and abuse — see our Security Policy for detail on how the service is architected.
Changes to these Terms
We'll update these Terms if how the service works changes materially — for example, if Regscribe adds paid tiers, persistence, or any feature that changes what's described above. We'll update the "Last updated" date when we do.
Governing law
[Placeholder — to be finalised once Regscribe's entity and jurisdiction are decided. Until then, these Terms are intended to be interpreted under the laws of England and Wales, consistent with our Privacy Notice and Security Policy.]
Contact
Questions about these Terms: info@regscribe.ai
This page was drafted 2026-07-31, informed by researching how comparable pharma/biotech QMS vendors (Veeva, ZenQMS, Qualio) structure their own Terms of Service — in particular ZenQMS's pattern of an explicit customer-owns-its-own-regulatory-compliance clause, which this page follows. Factual accuracy pass 2026-08-18: updated the product description to name the SOP overlap & consolidation tool and the Regscribe AI Governance module (both built after this page was first drafted), and widened the PHI-only data-handling clause to PHI/PII (the underlying upload-time attestation was widened 2026-08-17). A same-day correction: an intermediate edit briefly named Google alongside Microsoft as a sign-in option — auth.ts's own code confirms Microsoft is the only provider with real production credentials today, so that was reverted. No change to liability or warranty language. Factual accuracy pass 2026-11-06: added the New System tool (shipped 2026-09-17, a real gap this page hadn't caught until a parallel review session flagged it) to the product description, and updated the "Availability" language from "actively-developed prototype" to "live and in active use, currently in early access," with explicit language that it hasn't undergone formal GAMP 5 validation, matching the same change made to the homepage, Security Policy, and in-app badges the same day. The one remaining real blocker is the governing-law and entity placeholder below — that's a business decision (Regscribe isn't yet incorporated), not a legal-review gate, and this page is otherwise ready to publish as final the moment it's filled in.