Cosmetics manufacturing software for a MoCRA-regulated industry — not a repurposed food ERP.
Formulation with allergen and INCI awareness, batch record with in-process control, ISO 22716 GMP evidence, MoCRA facility registration, product listing and adverse-event workflow, EU CPNP-ready PIF assembly and a Part 11 audit trail. The cosmetics platform for a regulatory regime that just went from voluntary to mandatory.
You're shopping for cosmetics manufacturing software because MoCRA turned a voluntary regime into a federal one and your ERP has no idea what INCI means.
MoCRA facility registration and product listing lives in a spreadsheet
Adverse event workflow isn't tied to lot or facility
ISO 22716 evidence is stitched together at audit
INCI names and allergens live in the formulator's head, not the system
EU CPNP PIF is reassembled every time a market opens
Fragrance and colour subformulas break the batch record
Contract manufacturing customers each want their own reports
The cosmetics workflow, modeled and enforced.
Formulation with INCI + allergen
Formulas built with INCI-named ingredients, EU Annex III/IV/V/VI restrictions, EU 26-allergen threshold tracking, and safe-use-limit enforcement per market. Compliance is a property of the formula, not a downstream check.
Batch record + IPC
Structured batch record for compounding, mixing, filling and packaging with in-process control (pH, viscosity, colour, microbiological), deviation workflow and bound e-signature.
MoCRA registration + listing
Facility registration (renewed every 2 years), product listing per marketed product with responsible-person data, and update workflow when a formulation or facility changes.
Serious adverse event workflow
SAE intake, 15-business-day reporting clock to FDA, 6-year record retention, and lot-level linkage so a signal traces back to the batch and facility that made it.
EU CPNP + PIF assembly
Product Information File assembled from formula, safety assessment, GMP evidence and label — CPNP notification data ready to submit at market entry, refreshed automatically on formulation change.
Contract manufacturing multi-tenant
One instance, many brand-owner customers. Formula IP, batch records and reports partitioned by customer, with customer-facing portal for release documents.
What changes when cosmetics operations have a real system.
- MoCRA registration and listing stops being a spreadsheet
- SAE reporting clock is tracked and never missed
- ISO 22716 audit becomes a report extract, not a project
- EU CPNP PIF refreshes automatically on formulation change
- Allergen threshold breaches surface at formulation, not at label print
- Contract-manufacturing customer reports generate themselves
Every cosmetics regulator's checklist.
MoCRA (Modernization of Cosmetics Regulation Act 2022)
Facility registration (§606), product listing (§607), serious adverse event reporting within 15 business days (§605), safety substantiation records, fragrance allergen disclosure — all modeled natively.
ISO 22716 (Cosmetics GMP)
Personnel, premises, equipment, raw materials, production, finished products, quality control, waste treatment, subcontracting, deviations, complaints, recalls, internal audits, documentation — evidenced live.
EU Regulation 1223/2009
Responsible person, PIF, CPNP notification, Annex II–VI restricted-substance enforcement, 26-allergen threshold tracking (Annex III entries 67–92), CMR substance controls.
21 CFR Part 11
Bound e-signatures, hash-chained audit trail, RBAC. Reviewable, attributable, contemporaneous records per ALCOA+.
Cosmetics manufacturing software, answered.
What is cosmetics manufacturing software?
Cosmetics manufacturing software is the system of record for a cosmetics brand or contract manufacturer — INCI-aware formulation, batch record, in-process control, ISO 22716 GMP evidence, MoCRA facility registration and product listing, adverse-event workflow, and (for EU markets) CPNP PIF assembly. It replaces a spreadsheet formulator, a food-industry ERP and a shared drive of Word templates.
Does V5 support MoCRA?
Yes — natively. Facility registration (renewed every 2 years), product listing per marketed product, serious adverse event reporting within 15 business days with 6-year record retention, safety substantiation records and fragrance allergen disclosure obligations are all modeled and clock-tracked.
Does V5 support ISO 22716?
Yes. All 17 clauses — personnel through documentation — are mapped to platform objects. Evidence is captured live during batch execution and training, not compiled at audit time.
Does V5 handle EU cosmetics regulation 1223/2009?
Yes. Responsible person data, PIF assembly, CPNP notification data, Annex II–VI restricted-substance enforcement, and the 26-allergen threshold tracking under Annex III entries 67–92 are all native. When a formulation changes, the PIF and CPNP notification refresh automatically.
Can V5 run a contract manufacturing site with multiple brand-owner customers?
Yes. One V5 instance runs many customers with strict IP partitioning — formulas, batch records, IPC data and release documents are visible only to the owning brand. A customer portal surfaces released documents on their side without exposing anything else.
How long does implementation take?
Most cosmetics manufacturers run their first signed batch record within 30 days. Full multi-line rollouts including MoCRA listing, EU CPNP assembly and multi-brand contract manufacturing partitioning typically take 8–14 weeks.
Run cosmetics manufacturing under MoCRA the way food already runs under FSMA — in one platform, not five.
Free trial. Real cosmetics workflow. No sales gate.