Records, review and approval, and electronic signatures

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 Redraft the analysis to use new or withdrawn documents.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

1. 1Step 1: In Connected records, choose Link a record and enter its number (for example DEV-2026-0003).
2. 2Step 2: Choose the relation: Originates from, Resulted in, Implements, Affects, Supersedes or Related to. Add a reason if useful.
3. 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

• 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.

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 inbox lists what is Waiting for you, In progress and Approved in the last 30 days.

Electronic signatures

1. 1Step 1: Choose the signing action (Submit for review, Sign as reviewed, Approve and sign, or Sign: I have read and understood).
2. 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.
3. 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.

Reopening, cancelling and reinstating

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:

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