Changelog | QualiHQ

v0.13 20 May 2026

Design History File viewer

- Every release now has a Design History File view — a structured, auditor-ready document covering the complete design control record for that version: requirements, verification evidence, risk sign-off, dependency snapshot, open issues, CAPAs, document register, and completeness declaration
- A 7-point completeness score grades the DHF green, amber, or red. Each failing check includes specific guidance on exactly what to resolve and where
- The DHF is available at any stage — draft releases show a live preview so gaps can be identified and closed before approval

v0.12 13 May 2026

Risk management and post-market surveillance

- Per-release risk review: each release now includes a risk tab showing new and changed risk items since the previous version. Reviewers approve items individually and complete the review with an electronic signature
- AI-generated risk analysis: provide your product description and existing requirements and QualiHQ will produce a structured starter risk register covering hazards, probabilities, severities, and mitigations
- Post-market surveillance procedure generated automatically on account creation, covering monitoring tool placeholders, review cadence, alert thresholds, and assigned roles — ready to review and approve

v0.11 6 May 2026

Training records, dependency management, and safety classification

- Training records now tracked per document per team member. Training is assigned automatically when a document is approved, and the Team page shows completion status across the full team at a glance
- Dependency file import: upload a package.json, requirements.txt, go.mod, Gemfile.lock, or composer.json to populate your SOUP inventory in one step. Duplicates are updated automatically with a change count returned
- IEC 62304 software safety classification added to product settings. The selected class surfaces in release records and the Design History File

v0.10 5 May 2026

Approval security, traceability refinements, and compliance chain

- Strengthened electronic signature security across all approval actions, providing a stronger audit trail for regulatory submissions
- Traceability view refined for larger requirement sets
- Traceability matrix now shows the first release a requirement appeared in and the release in which it was last active, giving a clearer view of requirement history across versions

v0.9 29 April 2026

Design history traceability and dashboard overhaul

- New traceability matrix view showing the complete design control chain from approved requirements through verification methods to test evidence -- making full traceability easy to maintain and straightforward to demonstrate
- Compliance coverage chain added to the dashboard: five-stage visual showing how many requirements have been approved, verified, tested, and passed -- with drop-off counts at each stage
- Dashboard recommended actions reorganised into labelled groups by area -- requirements, documentation, issues, and releases -- each with a health indicator so the most urgent area is immediately visible

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

What we have shipped