Capability finder
Every answer carries our internal status: Shipped, Partial, Roadmap or Not planned. Uncovered questions go straight to a founder.
Plan, schedule, execute, report and close audits with a phase stepper, evidence capture and e-signed closure certificates.
Supplier-Lite: questionnaires and findings answered through a secure no-login link, with per-section assignment to the right owner.
The observation drafter produces regulator-quality drafts with citations and confidence scores; an auditor coach critiques clarity and evidence coverage privately.
Every audit’s phase, owner and risk visible at a glance, with at-risk filtering.
Findings become CAPAs automatically; triage, investigation, actions, effectiveness verification and e-signed closure.
RCA and 5-Why scaffolds drafted with citations, always reviewed and committed by a human.
Intake classifier, similar-event finder, disposition drafter and CAPA recommender — the module is functional and maturing.
Change requests with impact assessment, gated approvals and automatic training assignment.
Documents with versions, e-signed approval gates, AI classification/tagging and scheduled review reminders.
Append-only, SHA-256-hashed rows with user, UTC time and reason. No role can disable it; any question answered in <2s.
Password + meaning + reason-for-change on every signing event, bound to a hash of the signed record. Hard enforcement is rolling out as the production default.
"Show me everything about this CAPA over time" — field-level diffs across modules, in one view.
Validation Accelerator Package (vendor quality manual, IQ/OQ, traceability, pre-filled VAQ) included with every contract.
Grounded answers across 11 standards × 32 clauses, persona-aware playbooks (38 × 9 roles), SOP templates.
"Create an audit for X with Maria as lead on Aug 15" → reviewable plan → executed after a single e-signature.
Per-tenant provider preference across Anthropic, OpenAI and Gemini, with per-task overrides.
Cite-or-fallback is non-configurable: cited draft or "insufficient evidence — human input required". Never a fabricated answer.
Contractual default: zero training on customer data. Provider training opt-out enforced; certification issuable under DPA.
Your logo, colours and top-bar theme; tenant data fully isolated; "Powered by Smarthawk" attribution.
Buyer, auditor, supplier and admin roles with record-level permissions and cross-tenant access only via consented affiliations.
Region elected at provisioning; data never leaves it without explicit instruction.
PDF + CSV + JSON + audit-trail manifest within 7 business days; deletion with signed certificate within 30 days.
Assignment, due-date and escalation notifications; overdue reminders are partially rolled out.
Role-aware dashboards; a compliance health score for the VP Quality view.
Full REST surface with tenant/role enforcement and e-signature gates on regulated writes.
openFDA inspection/recall data and public registries fused into supplier intelligence dossiers.
Remote audit sessions scheduled and recorded through Zoom or Teams.
Escrow and data-export clauses available contractually for business-continuity assurance.
OCR + AI matching pre-fills PAQ fields from uploaded documents; the full document pipeline is still being wired.
SOC 2 Type I is in progress; controls are self-assessed today. Timeline shared under NDA.
Every accept/edit/reject on an AI draft is measured today; automated prompt tuning is on the roadmap — currently human-approved.
The platform is built on an i18n framework; English ships today, additional locales activate per demand.
Pricing is sites + named editors + AI usage — so it scales with your audit volume without per-audit metering.
Remote sessions with Zoom/Teams work today; the dedicated cockpit UI with in-tool evidence annotation is on the roadmap.
A predictor model exists internally; wiring it into the drafting flow is on the roadmap.
A forward-spec exists; the module is not in the current product. Partial groundwork only.
Forward-spec; complaints are handled today via Deviation & Event workflows.
Reports carry SHA-256 hashes today; third-party timestamp-authority anchoring is on the roadmap.
Designed and validation-gated (local model serving, customer infrastructure); being proven with design partners. Cloud multi-tenant is GA.
OIDC-based sign-in works today; SAML SSO and TOTP MFA are on the security roadmap.
The web UI is responsive today; a dedicated mobile companion is planned.
HMAC-signed, at-least-once webhook delivery is designed and on the roadmap; polling the REST API works today.
LabWare, STARLIMS, SAP S/4HANA Quality connectors planned; early integrators partner directly with our engineers.
Deliberately: regulated records deserve a managed environment. Instead — free synthetic Sandbox, then a free 60-day PoC on your real audits with success criteria in writing.
Design-partner conversations are open — early customers shape what gets built next.