MoCRA compliance software with facility, listing and AEs one system — safety substantiation and GMP-rule ready.
The Modernization of Cosmetics Regulation Act (MoCRA) gave FDA authority over cosmetics for the first time in 85 years. Facility registration, product listing (including fragrance allergens), adverse-event reporting for serious AEs within 15 business days, safety substantiation records, and readiness for the FDA GMP rule (which will draw heavily on ISO 22716). Written for Responsible Persons who don't want three parallel systems for register / list / report.
You're shopping because MoCRA landed on top of an ISO 22716 programme that wasn't built for FDA reporting.
Facility registration lives on someone's laptop and hasn't been updated after a move
Product listing isn't in sync with formula changes — fragrance allergen updates lag
Serious AE reporting relies on a paper log that misses the 15-business-day window
Safety substantiation is a folder per product that nobody can quickly locate
The looming FDA GMP rule will demand structural QMS work you haven't started
Responsible Person handoff between agencies and manufacturers is manual
MoCRA, run as one Responsible Person cockpit.
Facility registration + biennial renewal
Facility data (address, owner/operator, brands, product categories) with biennial renewal reminders and structured change handling for moves or ownership shifts.
Product listing (incl. fragrance allergens)
Product identity, brand, category, ingredients (including required fragrance allergen disclosure), and responsible-person data — auto-synced with formula master.
Serious AE reporting (15 business days)
Adverse event intake, serious-AE classification, and MedWatch 3500A submission workflow inside the 15-business-day window with audit trail.
Safety substantiation records
Per-product safety substantiation composite — tests, literature, historical use, and cumulative exposure — retrievable in minutes for inspector or attorney.
GMP-rule readiness on ISO 22716
The eventual FDA cosmetics GMP rule will draw heavily on ISO 22716. Sites running V5's ISO 22716 profile are structurally ahead when the final rule lands.
Responsible Person cockpit
One view for the Responsible Person spanning facility, listings, AEs, substantiation and GMP — no more three-systems-per-quarter reconciliation.
What changes the day this goes live.
- Facility registration and product listing stay in sync with reality
- Serious AE reports go out inside the 15-business-day window with evidence
- Safety substantiation for any product is one click, not a folder hunt
- GMP-rule readiness starts from an ISO 22716 baseline, not from zero
- Responsible Person owns one cockpit, not three logins
The frameworks a US cosmetics RP owns.
MoCRA (2022)
Modernization of Cosmetics Regulation Act — facility registration, product listing, adverse-event reporting, safety substantiation, records access, mandatory recall authority, and forthcoming GMP rule.
ISO 22716:2007
The GMP framework FDA has signalled it will draw from for the MoCRA GMP rule. Running ISO 22716 now is running MoCRA GMP prep now.
EU Regulation 1223/2009
For US brands also selling in the EU — the Responsible Person and Product Information File model shares record architecture with MoCRA obligations.
ISO 9001:2015
Document control (7.5), competence (7.2), nonconformity & CAPA (10.2), internal audit (9.2), management review (9.3) — all modeled, all evidenced.
ISO 13485:2016
Design controls, DHF/DHR/DMR, risk management hooks (14971), CAPA, post-market — same engine, device-grade controls.
FDA QMSR (2026)
Aligned with the harmonized QSR/ISO 13485 final rule effective Feb 2026. Your QMS doesn't have to be re-architected — V5 is already there.
MoCRA software, answered.
What does MoCRA require today?
Facility registration and biennial renewal, product listing (including fragrance allergen disclosure per FDA guidance), adverse-event reporting for serious AEs within 15 business days, safety substantiation records, and cooperation with FDA records requests. The GMP rule and fragrance allergen disclosure rule are being finalised on their own timelines.
What counts as a serious adverse event?
MoCRA defines a serious AE as death, life-threatening experience, inpatient hospitalisation, persistent or significant disability/incapacity, congenital anomaly/birth defect, infection, or significant disfigurement. Serious AEs must be reported to FDA within 15 business days using MedWatch 3500A.
Is MoCRA GMP already in force?
The MoCRA statute requires FDA to establish cosmetics GMPs. FDA is developing the rule and has signalled it will draw heavily on ISO 22716. Sites running a credible ISO 22716 programme now will be substantially closer to compliance when the final rule takes effect.
How does V5 handle Responsible Person handoffs?
The Responsible Person cockpit spans facility, listings, AEs, substantiation and GMP in one view, with role-based access for agencies, distributors and contract manufacturers acting on behalf of the RP — with audit trail on every action taken by a delegate.
Run MoCRA on one Responsible Person cockpit.
Free trial. Real facility, real listing, real AE reporting.