Identity testing enforced as a gate, not a certificate
Master manufacturing records per formulation and per batch size, identity testing enforced as a gate, and yield measured against theoretical at every control point. Validation-ready for 21 CFR Part 111 and FSSAI health supplement requirements, and kept current with regulatory change as part of the product, at no extra cost.
Every dietary ingredient gets tested. A certificate is not a substitute
Section 111.75(a)(1)(i) is the clause that fails audits. It requires at least one appropriate test to verify the identity of every component that is a dietary ingredient, before use. A supplier certificate does not discharge it. Certificates can be relied on for components that are not dietary ingredients, and only after you have qualified the supplier by confirming their results yourself, with the certificate stating the method, the limits and the actual results.
The second thing that catches plants is arithmetic. A master manufacturing record is required for each unique formulation and each batch size, so four products across three pack sizes is twelve records, not four, and they have to stay consistent with each other through every change.
The controls below run on the same compliance engine every industry uses.
What's tailored for nutraceuticals
Not just compliance mapping — here's where the modules themselves work differently for this industry.
Master manufacturing records generate per formulation and per batch size, inheriting a single formulation change under change control instead of twelve records drifting apart.
Separate attribution for weighing, verifying the weighing, adding and verifying the addition — each component, every batch.
Identity testing is enforced as a gate, so an untested dietary ingredient cannot be dispensed onto the floor.
20 controls, 6 standards
Select a standard to filter
Working draft, not a certified mapping — our own reading of each framework's published scope, not a legal determination.
Coverage by geography
We watch the regulations so you don't have to
Standards don't stay still. The Compliance Engine tracks every one that applies to you: when a rule changes, it tells you what it affects, updates the system, and re-validates before anything goes live. You don't file a change request. It's already handled.
Section 111.75 identity-testing gate
An untested dietary ingredient has never been dispensable in Factro — the gate was built in from the first pilot, not added after an audit finding.
EU novel-food authorisation status
An ingredient without significant EU consumption history before 15 May 1997 needs authorisation under Regulation 2015/2283 before it can be sold — the pack holds authorisation status against the material master and checks it at formulation.
EU permitted vitamins and minerals
Harmonised under Annexes I and II of Directive 2002/46/EC, but maximum levels and botanical substances remain national competence — the pack models permissibility per country.
Every update runs through the same validation discipline as the platform itself — tested against the workflows it touches before it reaches a single client's floor. Nothing ships because a regulation changed; it ships because the change passed.
The specification problem, in full
Section 111.70 asks for specifications in seven categories. Each is a separate approval object with its own change history, and proving that a released batch was tested against the version in force on that date is exactly the work a document-and-spreadsheet system loses.
Exporting changes the question
Validation readiness
The controls above are enforced in the architecture, not configured on top of it.
- Validation packs (URS, IQ, OQ, PQ, RTM, GAMP 5) are available on the Dedicated tier.
- ISO 27001 certification is in progress.
- Inspection readiness is scored continuously by the Compliance Engine, not assembled the week before an audit.
For the technical detail behind these controls — encryption, access control, audit trail mechanics and backups — see Infrastructure & Security. For what sits in each workspace, see Modules.
Have a compliance requirement to walk through?
Tell us about your regulatory environment and we'll show you exactly how Factro fits.