MoCRA-ready cosmetics manufacturing — facility, product, and adverse event records in one place.
Built for MoCRA, ISO 22716 Cosmetic GMP, and EU Cosmetic Regulation.
← Different industryThe codes you're accountable to — at the data layer.
Five steps from receive to release — with the regulator on the hook at the end.
Tap to expand · download as PNG · paste into an audit prep deck.
From login to release — no end-of-shift paperwork.
- › INCI
- › lot
- › weight
- › operator
- › recipe
- › phase order
- › temp
- › mix time
- › pH / viscosity
- › micro
- › QA sig
- › release
- › fill weight
- › AQL
- › operator
- › time
- › torque
- › label rev
- › lot
- › BBE
- › case count
- › pallet id
- › ship to
- › lot
- 07:00·step 01Approved formula
Today's compound runs against the approved formula = the basis of your MoCRA product listing. No edits without a new version.
MoCRA - 08:00·step 02Compound + fill
Operator weighs and blends. Each ingredient lot captured to the batch. Fill-line counts reconcile against label claims.
- 11:00·step 03GMP inspection
ISO 22716 micro + appearance checks logged at scheduled intervals. Out-of-spec → batch held.
- 13:00·step 04Stability / micro pull
Sample sent to lab. Result auto-attaches to the batch when the run completes.
- 15:00·step 05Adverse event ready
If a complaint arrives next year, every input lot + operator is one query away. AE link-back is built in.
MoCRA AER - EOD·step 06PIF live, not project
Product Information File assembles itself — it's a query, not a quarterly compilation.
The terms your auditor uses
- MoCRA
- Modernization of Cosmetics Regulation Act — US registration + AE reporting framework (since 2024).
- PIF
- Product Information File — required dossier under EU 1223/2009 for any product sold in the EU.
- Responsible Person
- Named entity legally liable for the cosmetic in the EU.
- ISO 22716
- International cosmetic GMP standard most auditors expect.
- AE / AER
- Adverse Event + Adverse Event Report — serious AEs must be reported to FDA within 15 days under MoCRA.
- CPNP
- EU Cosmetic Products Notification Portal — pre-market notification required in the EU.
Sound familiar? We built this for you.
Product listings and the actual approved formula drift apart over time.
Adverse event records aren't linked to the manufacturing lot they came from.
EU Product Information File assembly is a quarterly fire drill.
Contract manufacturing relationships make 'who is the responsible person' unclear at audit.
The record assembles itself as the work happens.
No paperwork project at end of shift. No reconstruction at audit time. The evidence IS the workflow.
Formula-to-listing tie
Approved formula version is the listing version. Changes flag the listing as out-of-date.
Adverse event linkage
AE reports tie back to specific manufacturing lots, raw material lots, and operators.
PIF assembled live
Product Information File is a query against the live data, not a quarterly project.
Co-man visibility
Brand-owner and contract-manufacturer roles, signatures, and responsibilities are explicit on every batch.
Spin up a workspace seeded for Cosmetics.
Default templates, validation rules, and report packs are pre-loaded for your industry. Run a real batch in under an hour.
Ask anything · No credit card · Onboard in days, not months