Regulatory and validation

# Regulatory impact and submissions
Screen a change for regulatory impact with a suggested reporting route per market, confirm each route as regulatory affairs, then draft submission sections in which every claim is sourced to a document and verified.
In the portal: [/app/submissions](https://qlogix.ai/app/submissions)

## The submission procedure
Regulatory impact screening - Person
1. Describe the change
Type, markets, change record attached

- AI drafts
2. Assess regulatory impact
Registered details affected, route per market

- Person
3. Decide each route
RA confirms or changes the category

- AI drafts
4. Draft sections
Every fact cites a source

- Person
5. Verify claims
Each claim verified or rejected

- Person
6. Approve sections

- Person
7. Record the decision

- E-signature
8. Review and approval

- The filing itself is made in your regulatory system; this record documents the assessment, the sources and the decision.

## Screen a change
- 1Step 1 : Open [Regulatory submissions](https://qlogix.ai/app/submissions) and choose New change.
- 2Step 2 : Choose the Type of change, give the change control reference, title and product.
- 3Step 3 : Tick the Markets where the product is registered: United States (FDA), European Union, United Kingdom (MHRA), Canada, Japan or other.
- 4Step 4 : Paste the change description, or attach the change control record, with impact assessments, specifications, validation reports, comparability or stability data and the registered dossier extract.
- 5Step 5 : Keep Assess the regulatory impact now ticked and choose Create and assess.

## Impact and reporting routes
The assessment states what changes, the registered details affected (CTD section, detail, effect, quote), a supporting-data checklist (provided, incomplete, missing), questions for regulatory affairs and an impact classification: prior approval likely, notification likely sufficient, likely no filing, or cannot determine.
Market Categories the AI considers
United States Prior Approval Supplement, CBE-30, CBE-0, Annual Report
EU and UK Type IA, Type IAIN, Type IB, Type II variation
Canada Level I Supplement, Level II Notifiable Change, Level III Annual Notification, Level IV
Japan Partial change approval or minor change notification

For each market choose the RA decision (with a reason): Suggested route confirmed, Different category (enter it), or No filing in this market.

## Sourced sections and the decision
- Draft section (AI): description of the change, justification, impact on quality, safety and efficacy, summary of supporting data, comparability, or cover letter (up to 12).
- Each fact carries a marker [C1] with the exact quote from its source; unsupported points are listed as not sourced.
- Open each claim and choose Verified or Rejected. Approve section (RA) needs every claim verified; approved sections cannot be edited. Set aside: not used with a reason.
- Record the decision: Proceed to submission (needs at least one approved section), No filing required: document in the change record, or More data needed before deciding.

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Source: https://qlogix.ai/docs/regulatory-submissions
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