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Framework

Does this label match the approved product facts?

A label PDF is checked against the approved product facts and FDA label law. An expert decides on the findings, and the decision is recorded.

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Label compliance decision flow 3 stages · 1 expert review
Label compliance decision flow, 3 stages in order. Stage 01, Gather the approved context. Stage 02, Prepare the findings. An expert decides: The resulting decision is recorded. Stage 03, Record what was reviewed.
  1. 01 Gather the approved context · ingest
  2. 02 Prepare the findings · transform
  3. An expert decides Unresolved questions and required approvals
    they see The review packetFindings tied to each criterionWhat was reviewed before
    they decide The resulting decision is recorded
  4. 03 Record what was reviewed · neutral

Your tools handle the tasks. The decisions still wait for you.

Every business has a Friday pile: the calls that sit all week until the busiest expert gets to them. For a supplement brand it is the label that waits for the one person who knows the product facts and the FDA rules. Framework brings the label, the approved facts and the rules together, so the expert only has to make the call.

Your expert decides. The rest moves on its own.

This is one label review, in the compliance manager’s own tools. The marked-up proof and its findings wait in their SharePoint Outbox, each finding tied to the FDA rule it checks. They keep or ignore each one, with a reason. The decision is recorded, and the designer gets the changes in Outlook, minutes after the proof came in. Nothing to migrate, and every decision has a page.

  1. The artwork, the marked-up file and the report wait in the Outbox in Microsoft SharePoint.
  2. The compliance manager compares the artwork with the markup and the findings, each with its 21 CFR citation.
  3. They keep or ignore each finding, with a rationale for any they ignore.
  4. The decision is recorded and saved back to SharePoint.
  5. The designer gets the changes in Microsoft Outlook.

Before and after

Before

Each label checked by hand against the product facts and the FDA rules, by the one person who knows both.

After

Findings tied to each rule arrive in one review packet. The expert decides, and the decision is recorded.

One decision, walked through

01 · Inputs
A label PDF for a supplement, its approved product facts, and the label as last approved.
02 · Rule
FDA label law (21 CFR 101) and your agreed review criteria.
03 · Permitted action
Findings are tied to each criterion. A mismatch between the label and the approved facts is flagged with the reason.
04 · Outcome
The expert reviews the packet and decides. The decision and what was reviewed are recorded.

“How do I know it’s right, and is my data safe?”

You approve first
The expert decides on every finding. Nothing is released on Framework’s say-so.
Every decision has a page
The label, the approved facts, the rule and the expert’s call, recorded together.
Your systems stay in charge
Framework reads the label and the facts where they already live, in Outlook and SharePoint. Your artwork and approvals stay where they are.

Hand off this decision. Done by Friday.

Have labels that wait on one expert? Start there.

Book a Friday Pile session

A 30-minute session, one decision flow scoped, live by Friday, reviewed after 30 days.