CONTROLLED IFU PUBLICATION GUIDE
Independent review, approval, publication and withdrawal
Uploading a PDF is different from publishing it to users. Keep preparation, independent review, publication scope and withdrawal as distinct decisions in your document workflow.
Application guide · Updated 5 October 2026
Define product mapping, document type, revision, language, audience and countries. Track the file security scan. A clean scan is a technical check; it does not prove that instruction content is correct or compliant.
Move the draft into review. The authorised reviewer must be different from the person who uploaded the file; uploaders cannot approve their own document. Record the reason when corrections are required and prepare the corrected file for a new review.
An approved document is not automatically published in the portal. Before publication, the platform checks the file scan, current risk assessment, paper request contact and approved product, market and audience scope. Missing required approved language versions can prevent publication.
Review language files included in the publication plan. After publication, test the product link with the actual audience, country and document language choices. Track the publication date, scope basis and action history; check notification records separately from document access.
A reasoned correction decision during review concerns content that has not yet been published. Withdrawal is a separate authorised action, with a reason, for a published revision. Verify access to the withdrawn revision and the remaining approved document scope separately. Hiding a link alone does not replace a controlled withdrawal record.
A new publication can queue notifications for relevant verified revision follows. Queued, sent and delivered are different states. For safety-related changes, voluntary followers do not guarantee coverage of every affected user; the manufacturer must separately complete the communication scope, owners and evidence. This guide describes the platform workflow and does not replace quality or regulatory assessment.
No. Approval requires an authorised reviewer who is different from the uploader. Role permissions and reviewer independence are assessed together.
A file scan, current risk assessment, product and market scope or required approved language version may be missing. Complete the gap and reassess the publication plan; an approved status alone is insufficient.
Keep revision and decision records connected to the same document and product. Workspace history and the version offered in the portal are different concepts; do not assume every earlier file is public.
A withdrawal record alone does not prove that every user has been informed. Assess affected document access, safety communication scope and notification or delivery evidence separately.
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