Six modules · one platform

A complete QMS,
built for regulated teams.

Document control, quality events, supplier management, training, audit trail, and notifications — on one platform with public pricing.

Document control

Version-controlled documents with multi-stage review and approval, periodic review reminders, and rich-text section editing. Every approved revision generates a watermarked PDF for controlled distribution.

  • Full version history — every change tied to the user who made it, the time, and the reason for change
  • Configurable multi-stage review and approval workflows — sequential or parallel approvers per stage
  • Periodic review scheduling with automated reminders before the due date
  • Custom document numbering schemas per template (e.g. SOP-001, MAN-Q-001)
  • Watermarked PDF generation with status-appropriate labels (DRAFT, UNCONTROLLED COPY, SUPERSEDED)
  • @-mention users and #-reference other documents inline in comments and review threads
Document control

Quality events

CAPAs, NCRs, customer complaints, audit findings, recalls — built from configurable templates. Each stage captures the fields auditors actually ask for: investigator, methodology, root cause, effectiveness criteria, verifier.

  • Configurable stage-based workflows — define your own stages, required fields, and approvers per template
  • 21 CFR Part 11 e-signatures on every stage approval and rejection, with password re-authentication per signing
  • Required fields per stage with optional conditional fields (show MDR-reportable-only fields when applicable, etc.)
  • Root-cause method capture across 5-Why, Fishbone, Fault Tree, and Pareto
  • Visible rejection state with rejecter comments when a stage needs revision
  • Controlled PDF export of the entire event record, with optional audit-trail appendix
  • Pre-built event templates in every compliance pack (see Compliance Packs below)
Quality events

Supplier management

Onboard, qualify, and re-evaluate suppliers as first-class records, not spreadsheet rows. Each supplier carries its own attachments, audit history, and links to the quality events it affects.

  • Onboarding questionnaires with sponsor + approver workflows
  • Risk classification and qualification approval gates
  • Scheduled re-evaluation cycles with reminders ahead of the due date
  • Document attachments per supplier — quality agreements, certifications, audit reports
  • Link suppliers to quality events for traceability when an NC traces back to a vendor
  • Approved supplier list view, filterable by risk and category
Supplier management

Compliance packs

Six pre-built packs deploy dozens of starter documents and auditor-grade event templates in one click. Edit what doesn’t fit; the originals stay as your reference.

  • ISO 13485 Starter — 51 documents + 4 event templates (CAPA, NCR, Customer Complaint, Audit Finding)
  • ISO 9001:2015 — 37 documents + 4 event templates (CAPA, Complaint, Internal Audit, Improvement Initiative)
  • Dental Practice — 21 documents + 4 event templates tuned to OSHA 29 CFR 1910.1030 and CDC infection-prevention guidance
  • Food Safety / HACCP — 31 documents + 5 event templates (CCP deviation, complaint, EMP positive, supplier NC, recall) aligned with FSSC 22000, SQF, BRCGS, and FSMA
  • Software-as-medical-device — IEC 62304-aligned procedures and templates
  • Validation — IQ / OQ / PQ templates for computer system validation
Compliance packs

Audit trail & e-signatures

Every record change is logged with user, timestamp, and per-field old/new values. Tied to e-signatures on every quality-record decision. Exportable as an appendix on any controlled PDF.

  • Immutable audit log across documents, events, suppliers, training, and admin settings
  • Per-field change tracking — old value, new value, optional reason for change
  • 21 CFR Part 11-aligned e-signatures with name, date/time, and meaning of signature
  • Password re-authentication required on every signing — no "stay signed in" loophole
  • Filterable history per user, record, or date range — answer "who changed this" in seconds
  • Audit-trail appendix bundled into PDF exports of documents and quality events on request
Audit trail & e-signatures

AI integration (MCP)

Connect Claude, ChatGPT, Gemini, Cursor, or any MCP-aware AI assistant directly to your QMS via the Model Context Protocol. Twenty tools let an assistant browse, search, read, and draft — with the regulated audit trail intact.

  • OAuth 2.1 with PKCE for claude.ai web connectors (Dynamic Client Registration, short-lived JWTs)
  • Static Bearer tokens for Claude Desktop, Claude Code, and Cursor
  • Per-integration scopes — read-only or read & edit drafts
  • AI can draft documents, open quality events, fill in stage fields, comment, and search; cannot sign, approve, reject, submit-for-review, or make documents effective
  • Every MCP call is logged to the tenant audit trail with tool name, auth mode, user, and IP
  • Tenant-scoped row-level-security on every request — a token can never see another tenant
  • Backed by the open Model Context Protocol — Claude, ChatGPT, Gemini, Cursor, Continue, Zed, and any MCP 2025-03-26 client work without code changes on our side
"Draft an SOP for incoming inspection."
→ list_document_templates
→ create_document (SOP-78)
→ update_document_section ×6
→ update_document_compliance_fields
✓ Draft ready for human review

Training & notifications

Assign training individually or to groups, track completion, and let the system chase people for approvals so you don’t have to.

  • Group-based training requirements — add a user to a group, they inherit every required training
  • Email alerts for pending reviews, approvals, training assignments, and signature requests
  • Periodic-review reminders fire before documents go out of effective date
  • Supplier re-evaluation reminders ahead of the due date
  • Per-user notification preferences with optional daily digest mode
Training & notifications

See it in your own tenant.

Sign up in 30 seconds, deploy a compliance pack, and you’ll have a working QMS with 21–51 starter documents this afternoon.

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