Changelog
What we have shipped
A running record of what has changed and when.
v0.8
22 April 2026
Regulation guides, onboarding refinements, and test infrastructure
- - Added a free guides section covering medical device regulation for software teams. Plain-English explanations of EU MDR, SaMD classification, and when your app needs a QMS
- - Streamlined the new account setup flow. The DPA step is now added to settings and setup now completes faster with fewer decisions upfront
- - Expanded automated end-to-end test coverage across core workflows including sign-in, onboarding, and document approvals
v0.7
15 April 2026
Onboarding, in-app guidance, and security hardening
- - Added a getting started checklist that persists across every page, tracking setup progress from first bootstrap through to first release and team invite
- - Added a three-step QMS explainer on first login covering how requirements, verifications, test runs, SOPs, releases, and audits work in plain language
- - Required SOP templates now ship with every new account and are flagged in the documents table until approved
- - Security: XML upload hardened against external entity injection, rate limiting added to all AI endpoints, login brute force protection tightened, API tokens now expire after 30 days, password complexity enforced on registration
v0.6
8 April 2026
Release UI overhaul, security hardening, and public changelog
- - Rebuilt the release approval UI with a cleaner step-by-step flow and inline warnings for missing verifications or unreviewed risk items
- - Security hardening: Content Security Policy headers tightened, security.txt published, GDPR sub-processor records updated
- - Added this changelog
v0.5
2 April 2026
Smarter AI linking and traceability improvements
- -- Significantly improved how the AI links requirements to verifications -- higher accuracy on ambiguous or overlapping requirements
- -- Traceability matrix now shows link confidence and flags any requirements with no verification coverage before you proceed to release
- -- Priority system added to requirements: each item now carries a risk-weighted priority score to help teams focus review effort
v0.4
26 March 2026
Onboarding overhaul and bootstrap improvements
- -- Simplified the bootstrap wizard from five steps to three -- describe your product, add test results, review and apply
- -- New users can go from signup to a populated QMS in under two minutes
- -- Context input imporvements for onboarding including a full detailed design doc or README
v0.3
19 March 2026
Release workflow and audit trail
- -- Release approval workflow shipped: releases are now blocked until all verifications are linked and the risk assessment has been reviewed
- -- Full audit trail: every action logged with timestamp, user, and context
v0.2
14 March 2026
AI bootstrap shipped
- -- AI bootstrap: describe your product and get a complete QMS structure generated in seconds -- requirements, verifications, risk analysis, and traceability matrix
- -- Requirements include references to the relevant parts of your codebase, derived from the context you provide
- -- Issue tracking and CAPA management
- -- Team invites and role-based access
v0.1
10 March 2026
First release
- -- QualiHQ is live
- -- Requirements management, verifications, and test case tracking
- -- Risk analysis with hazard identification and mitigations
- -- Release management, issue tracking, and CAPA workflow
- -- Traceability matrix linking requirements, verifications, and test evidence
- -- HTTPS enforced, rate limiting in place, security headers configured