Getting started

# Records, review and approval, and electronic signatures
The procedures shared by every record: editing with reasons, attachments, connected records, routing for review and approval, electronic signatures, reopening, cancelling and controlled exports.
In the portal: [/app/reviews](https://qlogix.ai/app/reviews)

## Editing and reasons for change
- Choose Edit or Change beside a value, make the change and give the Reason for change (required). The old value, new value, reason, your name and the time go into the audit trail.
- No reason is needed when creating a record, making a first decision, recommendation or disposition, writing a first note, or entering a first result or reference.
- Nothing is deleted. Causes, actions, exceptions and signals are dispositioned (ruled out, rejected, not an exception) instead.
- Several people can edit at once. If someone changed the same field after you opened the record, your change is refused with their name and the time; reload and make your change again.

## Attachments
- Accepted: PDF, Word (.docx), Excel (.xlsx), text, CSV, Markdown and images (.png, .jpg). Save .doc and .xls as .docx, .xlsx or PDF first.
- Up to 20 MB each and 12 active documents per record; up to 28 MB are read together in one AI run.
- Each file is fingerprinted (SHA-256) and numbered D1, D2…; the AI re-reads it from storage and checks the fingerprint every time.
- Withdraw a document (with a reason) to take it out of the analysis; it stays on the record. Redraft the analysis to use new or withdrawn documents.

## Connected records
- 1Step 1 : In Connected records, choose Link a record and enter its number (for example DEV-2026-0003).
- 2Step 2 : Choose the relation: Originates from, Resulted in, Implements, Affects, Supersedes or Related to. Add a reason if useful.
- 3Step 3 : Back-links show under Linked from. Related, not linked yet suggests records that share lots, equipment, documents, products or cause wording; link them one at a time or all at once.
Removing a link needs a reason. A record holds up to 40 links. Signed records cannot be linked or unlinked until reopened.

## Review and approval
Routing a record for review and approval - Person
1. Assign people
Author, 1 to 6 reviewers, 1 to 6 approvers, all different

- Person
2. Save assignments

- E-signature
3. Submit for review
Author signs (Authored); content frozen

- E-signature
4. Each reviewer signs
Sign as reviewed (Reviewed)

- E-signature
5. Each approver signs
Approve and sign (Approved)

- System
6. Approved
Final cycle signs and locks the record

- Return to author / Reject (comment required) → back to draft; a new cycle; everyone signs again.
- Withdraw from review (author, reason required) → back to draft.
- Reassign someone (author, reason required) → a pending reviewer or approver is replaced.
- Review and approval needs at least three people: the author, a reviewer and an approver, all different and in your organization. Functions (QA, Production, QC laboratory, Engineering, Regulatory affairs, Validation…) and a due date are optional.
- Only the author submits. The record's creator can hand authorship to a subject matter expert. Assignments change only in draft; afterwards use Reassign someone.
- While routed, content is frozen. The author withdraws it, or a reviewer or approver returns it, to make changes.
- The author cannot review or approve their own record, nobody both reviews and approves, and each person acts once per cycle in their role.
- Revision: the first routing is Rev 1; a resubmission is the next revision only if the content changed.
Record Review cycles ("This review is for")
Change control Approval to implement (milestone), then Closure (final)
CAPA Plan approval (milestone), then Closure (final)
Controlled document Approval (final; makes the version effective or obsolete)
Validation project Validation plan approval, then Validation closure
Validation document Approval (protocols before execution, reports after)
Every other record Review and approval (final)

Emails go out automatically: to the author when assigned, to reviewers on submission, to approvers when all reviewers have signed, to everyone on approval, and to the author on return or rejection. The [Reviews and approvals](https://qlogix.ai/app/reviews) inbox lists what is Waiting for you, In progress and Approved in the last 30 days.

## Electronic signatures
- 1Step 1 : Choose the signing action (Submit for review, Sign as reviewed, Approve and sign, or Sign: I have read and understood).
- 2Step 2 : Enter Your email (the account you are signed in with) and Your password. The password is checked with the identity provider and never stored.
- 3Step 3 : Confirm. The signature records your name, email, role, the meaning (Authored, Reviewed, Approved or Read and understood), the time, the record version and a SHA-256 of the content.
Rule: An electronic signature is the legally binding equivalent of your handwritten signature. Five wrong passwords in 15 minutes lock signing for 15 minutes; you are emailed and the event is logged.

## Reopening, cancelling and reinstating
Action Who Rule
Reopen for changes Administrator Reason required; starts a new cycle with the same people; earlier signatures stay on the earlier version
Cancel this record Creator, author or administrator Justification of at least 10 characters; not while in review; the record keeps its number, content and audit trail and reads Cancelled everywhere
Reinstate record Administrator Reason of at least 10 characters

## Exports and controlled copies
The Export panel gives PDF, Word (.docx) and Audit trail CSV. Each export is logged. The PDF and Word copies hold the record content, the signatures and the full audit trail, stamped by state:
Stamp When Footer
APPROVED (with approval and effective dates) Final approval signed Controlled copy
NOT CLOSED A milestone approved (plan approval, approval to implement) Uncontrolled
IN REVIEW (with who it is waiting for) Routed for review or approval Uncontrolled copy (in review)
DRAFT Not routed or not approved Uncontrolled draft

A controlled document is effective on the effective date set before approval; any other record on its final approval. Printed copies are uncontrolled.

---
Source: https://qlogix.ai/docs/records-and-signatures
QLogix · contact@qlogix.ai · +17146639012