Upload an SOP, policy, batch record, CAPA, or deviation. Regscribe checks it against the applicable regulation or standard — from FDA/EU GxP to ISO, GDPR, and PCI DSS — plus structural and signature integrity, and what a real compliance platform would require, in one pass. Upload a whole SOP library and it'll also find where documents overlap or contradict each other, and flag genuine consolidation candidates.
Local prototype, invite-only. Document content is sent to Anthropic's API to run the analysis and isn't retained — see our Privacy Notice for what we do keep (a sign-in allowlist and an audit-trail record). Curious how the verdict is actually decided? See how the readiness gate works.
✓ Ready to publish
Checked against FDA 21 CFR Part 11 or EU GMP/GDP, clause by clause — with severity tiers that respect enforcement-discretion nuance rather than flagging everything equally.
Structure, dates, and signatures — including visually confirming a signature block is actually signed, not just mentioned in the text.
Owner, approver, effective date, review cadence, version control — modeled on how real QMS/ISMS/compliance platforms like Veeva, Qualio, ZenQMS, and GRC tools gate a document before it goes live.
Spelling, grammar, and formatting-consistency issues flagged for human review — advisory only.
Upload a whole SOP library at once — Regscribe maps which clauses each document covers, finds gaps no document addresses, and flags genuine consolidation candidates with an evidence-grounded recommendation.
AI Governance is a separate module for pharma and biotech teams evaluating AI vendors and tools — a genomics platform, a clinical NLP tool, a manufacturing anomaly detector. Before you acquire, it runs the vendor through a risk-tier classification and compliance assessment against the EU AI Act and, where the tool touches patient data, HIPAA — with a deterministic approved / conditional / rejected verdict and every blocking or conditional finding named. (Ongoing post-acquisition inventory tracking is on the roadmap, not built yet.)
Drop in a PDF — an SOP, CAPA, deviation, change control, batch record, or training record.
Checked in parallel against a regulation or standard, document integrity, document-control metadata, and proofreading.
A clear ready / needs review / not ready call, with the specific reasons named — not a black box.