Regulatory Checks

The Regulatory Checks page is the InnoQualis EQMS compliance command center. It pulls together every regulator change that the platform is monitoring on your behalf, runs each change through an AI gap analysis against your live documents, and surfaces the findings here so quality teams can decide what to do — without leaving the page.

Who uses it

Role	Access	Typical action
Admin (Quality Manager / Quality Lead)	Full	Reviews findings, approves change requests, configures the standards registry.
QA_Team	Full	Triages new findings, opens change requests, drafts new document versions.
Auditor	Read-only	Inspects findings + actions taken (audit-trail context).
User	No access	The page requires the `compliance.read` permission, which is not granted by default to the User role.

The page is reachable from the left sidebar under the Quality group as Regulatory Checks. Direct URL: /regulatory-checks.

What you see

The page has two sections stacked vertically:

1. Dashboard cards

Five summary cards across the top:

Compliance Score — percentage of tracked findings that are already closed out (accepted or resolved). Colour-coded green / amber / red.
New Updates — total regulator changes the platform is tracking for your tenant.
Pending Findings — open impacts awaiting a QA decision.
Resolved This Month — findings closed in the current calendar month.
Avg Response Time — average days from when a finding was raised to when it was closed.

2. Findings table

A filterable, sortable, paginated list of findings. Each row shows the affected document, the impact type, a short gap description, the severity (critical / major / minor), the AI confidence score, and the current status.

Available filters:

Severity — critical, major, minor, or all.
Status — pending, accepted, rejected, deferred, resolved, or all.
Standard gating — actionable, pending purchase, not applicable, or all.
Min confidence — slide the threshold to hide low-confidence AI findings.

Page size: 10 / 25 / 50 / 100. The default is 50; the platform hard-caps a single request at 200.

Drill into a finding

Click any row (or its Expand button) to open the split-layout detail:

Left column — the affected document content with highlights. Yellow marks identify non-compliant text, red marks identify missing content, green marks identify suggested additions. Click a highlight to scroll the gap analysis to that range.
Right column — the gap analysis: the regulatory reference (standard + clause), a plain-language gap explanation, a current → suggested diff, an effort estimate badge, and four action buttons.

If the underlying document is a binary file (PDF, Office) rather than rich-text, the left column shows a download link instead of the highlighted preview. The gap analysis still applies — the highlighting overlay for binary files will land in a follow-up release.

Four ways to act on a finding

The right column always exposes four action buttons. They write to the audit trail under the user’s identity, so the chain of evidence for the decision is preserved.

Action	What happens	When to use
Create Change Request	Files a Change Control pre-populated with the AI gap analysis, links the affected document, and flips the impact to `accepted`.	The change is non-trivial and benefits from the formal Change Control workflow (impact assessment, approvals, training).
Create New Version	Cuts a new draft `DocumentVersion` with the suggested wording applied at each highlighted range. The draft enters the normal approval workflow before becoming effective.	The change is small, the suggested wording is correct as-is, and a Change Control feels heavy.
Reject	Closes the finding as not applicable. A rejection reason is required (21 CFR Part 11 needs a written justification on every decline).	The AI’s reading is wrong, or the finding does not apply to this document.
Defer	Postpones the decision. A reason is optional.	The finding is valid but the team needs more time (e.g. waiting on a related change).

Both Create Change Request and Create New Version are idempotent — calling them twice on the same impact returns the existing record instead of creating a duplicate.

When a finding references a standard your tenant has not yet activated (purchased), an amber Standard Gating banner appears above the gap analysis, and the Create Change Request / Create New Version buttons are disabled. The banner links directly to the Standards & Regulations admin tab where an Admin can activate the missing version. Reject and Defer remain enabled so you can still close out a gated finding if it’s not applicable to your operation.

Permissions reference

The page requires compliance.read. Without that permission the user is redirected back to the dashboard.

To act on findings, the user additionally needs:

change_control.create to use Create Change Request
documents.update to use Create New Version

These are the same permissions used elsewhere in the platform — the regulatory page does not introduce new permission strings.

Standards & Regulations (admin) — activate the standards your tenant should be checked against.
Change Control — what happens after Create Change Request.
Document Control / Versioning — what happens after Create New Version.