Demo it. Show it. Close it.
Everything you need to walk a cosmetics client through ComplianceWorxs live — MoCRA-grounded sample records, the three conversations that convert, and the exact pay math behind every referral.
MoCRA turned cosmetics from a self-regulated category into an inspection-governed one. Most brands are still documenting like the old regime. The gap is no record of decision logic at the moment of action — and FDA now has the authority to ask for it.
Your client has product listings registered. Facility registration filed. Safety substantiation files somewhere on a server. What they don't have — and what an FDA investigator is now empowered to demand — is a record that shows who authorized a specific decision, based on what evidence, and why it was justified at the moment the decision was made. Safety substantiation. Adverse event determination. Serious vs. non-serious classification. Recall triggers. That's what ComplianceWorxs produces. That's what you're referring clients to.
Four MoCRA pillars. Five decisions. One gap.
Your client knows MoCRA exists. What they may not have mapped is where the structural failure points are under inspection. This is the frame.
Investigators don't audit systems — they test specific decisions. These are the five decision points where cosmetics programs structurally break down under MoCRA inspection, and where a defensible authorization record is either present or absent:
- Safety substantiation sufficiency — Who determined this product's safety substantiation record is adequate, based on what evidence, and against what criteria?
- Adverse event classification — Who decided this complaint was non-serious (not requiring 15-day FDA report) vs. serious? On what basis, and who else reviewed that call?
- Responsible person designation & change — Who authorized the designation or change of the responsible person on record, and what review preceded it?
- Ingredient change or supplier substitution — Who authorized a change in ingredient source, grade, or supplier without triggering re-substantiation of product safety?
- Recall initiation (or decision not to) — Who evaluated the adverse event cluster, stability failure, or contamination signal and authorized the go/no-go on voluntary recall before FDA compelled it?
Three free tools. Each does a different job.
You don't have to sell ComplianceWorxs. You point your cosmetics client to the right tool at the right moment, and the tool does the work. Here's what each one is for.
Decision Trail Assessment
A 20-question inspection simulation. The ComplianceWorxs platform was originally built for pharma 21 CFR 211 decisions, but the underlying logic maps directly to MoCRA. Your client works through three real records: their most recent safety substantiation review, their last adverse event classification, and their most recent ingredient or supplier change authorization. The results page shows them exactly where their decision trail won't hold up if FDA asks for it.
When to use it: Client is preparing for a facility inspection under the new MoCRA authority. Client is scaling into new product categories and their substantiation files haven't kept pace. Client is new regulatory or compliance leadership reviewing the program. An adverse event cluster, a consumer complaint spike, or an FDA letter has everyone's attention.
What it leads to: Another IRR — a systemic problem shows up decision by decision.
Take the Assessment →Paste-Your-Record Tool (Homepage)
Live on the ComplianceWorxs homepage. Client pastes the actual justification language from one of the five decision points — a safety substantiation conclusion, an AE serious/non-serious classification reasoning, an ingredient change authorization. The tool drafts inspection-ready reasoning in 90 seconds, then shows them exactly what an FDA investigator would still ask that their record doesn't answer.
When to use it: Client is fixated on one specific decision they're worried about — an AE they classified as non-serious that now looks borderline, a substantiation file they signed off on under time pressure, an ingredient substitution that never got re-reviewed. Screen share this live.
What it leads to: Inspection Response Record ($497) — a defensible artifact for that one decision.
Open the Homepage Tool →The Inspection Record
The editorial companion site. Articles, a 483 observation library, and a lighter diagnostic. Use it for clients you're nurturing — regulatory leads at cosmetics brands who read your posts on LinkedIn but aren't ready for a product conversation. It feels like editorial, not a funnel.
When to use it: Content-first outreach. LinkedIn replies. Warm-up sequences with a regulatory or quality lead who doesn't know you yet.
What it leads to: Back into the ComplianceWorxs product stack once they engage.
Visit The Inspection Record →Three records. Three of the five decision points. Paste these on a screen share.
Each sample below lands on one of the five decision points: safety substantiation sufficiency, adverse event classification, and ingredient change authorization. They're realistic cosmetics brand scenarios — built to show a client exactly what happens when standard MoCRA-era documentation meets the question an FDA investigator is trained to ask.
How to use: Share your screen. Open complianceworxs.com. Paste the record below. Watch the tool produce inspection-ready reasoning. Scroll to the hard contrast line at the end: "An inspector does not ask for better language. They ask who authorized this decision, based on what evidence, and why it was justified." That's the moment your client realizes the gap is real.
Product: Hydra-Renewal Moisturizer (SKU HRM-2024-03) Substantiation Review — File Reference SS-HRM-2024 Safety substantiation record for Hydra-Renewal Moisturizer reviewed for adequacy per FD&C Act §608. File contents: ingredient-level safety assessments sourced from supplier Safety Data Sheets, CIR (Cosmetic Ingredient Review) monographs for 14 of 17 ingredients, internal skin compatibility testing (HRIPT, n=52 subjects, no reactions above grade 1), stability data at 25°C/60% RH and 40°C/75% RH over 12 weeks, and preservative efficacy testing (USP 51 challenge). Ingredients without direct CIR monograph entries reviewed against supplier safety documentation and concentration levels in predicate products. Regulatory Affairs concluded safety substantiation is adequate for the intended use and target population. Product released to market Q2 2024. Substantiation file archived per retention schedule. Responsible Person sign-off complete.
Why it's a good demo: The file looks complete by traditional cosmetics standards. But under MoCRA §608, an FDA investigator can now ask who evaluated the adequacy conclusion on the three non-CIR-monograph ingredients, what specific criteria governed accepting supplier documentation as sufficient, and what review occurred separate from the file assembly itself. The signature names a Responsible Person but doesn't capture the authorization logic behind the adequacy determination. "Adequate for intended use" is a conclusion, not a decision record.
AE Report AE-2024-0817 — Classification Disposition Consumer complaint received 03-Aug-2024 via customer service portal. Reporter: adult female, age 34. Product: Hydra-Renewal Moisturizer. Described reaction: "burning sensation and redness across cheeks lasting approximately 48 hours following first application, resolved without treatment." Report triaged by Quality team. No hospitalization. No medical intervention described. No permanent impairment. Reaction resolved within standard timeframe for mild irritant response. Reporter did not consult a healthcare professional. Classified as non-serious adverse event per FD&C Act §605 definitions. Entered into AE log. No 15-business-day FDA reporting obligation triggered. Case closed with consumer refund and product return. QA reviewer signature complete.
Why it's a good demo: Classification as non-serious is plausible on these facts. But MoCRA §605 classification decisions are now one of the highest-exposure calls a cosmetics brand makes — because if a cluster develops and any one of those "non-serious" classifications gets second-guessed on inspection, the 15-day reporting obligations chain back. There's no record of the criteria the reviewer applied, no capture of whether a second reviewer concurred, and no trail showing the classification was evaluated against the full text of §605 rather than a summary. When an investigator asks "who authorized this classification as non-serious, and under what decision framework," a QA signature isn't the answer.
Change Control CC-2024-0412 — Ingredient Source Substitution Product family: Clarifying Cleanser line (SKUs CC-100, CC-101, CC-102) Change: Glycerin source substituted from Supplier A (vegetable-derived, pharmaceutical grade) to Supplier B (vegetable-derived, cosmetic grade) due to Supplier A supply disruption. Technical review: Supplier B CoA reviewed. Specifications meet or exceed Supplier A on identity, purity, water content, heavy metals. Compatibility with formulation confirmed by bench-scale evaluation and 4-week accelerated stability (40°C/75% RH). No visual, sensory, or pH changes observed. Determined equivalent for in-use performance. Existing safety substantiation file considered unaffected by this change as glycerin identity and functional role in the formulation remain unchanged. No re-substantiation triggered. Change implemented across CC-100, CC-101, CC-102 effective 15-May-2024. Change control record filed. R&D and QA sign-off complete.
Why it's a good demo: The equivalence reasoning is defensible on technical grounds. But under MoCRA §608, the decision to treat an ingredient source change as not triggering re-substantiation is itself a decision FDA can now probe. There's no record of who specifically authorized the "no re-substantiation" determination, against what documented criteria, or what review preceded it. "Considered unaffected" is the conclusion. The question is who decided the substantiation file was unaffected, and on what authority. This is exactly the type of decision that surfaces under inspection when an AE cluster or stability issue emerges in a changed lot six months later.
Three client conversations. Three scripts.
You don't sell the product. You name the moment. These are the three situations where a ComplianceWorxs referral writes itself for a cosmetics brand under MoCRA.
Bridge for the client: "The page uses pharma vocabulary — CAPA, batch release. Translate those as your substantiation reviews and AE classifications. FDA's decision-logic bar under MoCRA is the same bar pharma has been held to for decades."
Next move after results: If they score 8+ gaps, recommend they order another IRR for the next decision under scrutiny. This isn't a one-decision problem.
Next move: After the tool exposes the gap, point to the IRR at $497. One authorization record, generated from the customer's own documents. This is a single-decision fix, not infrastructure. Good for clients who want to repair one specific exposure before it compounds.
Next move: Recommend another IRR ($497) for the next decision under scrutiny.
What you earn, by product.
25% commission on every verified referred transaction. Commissions pay Net 30 after month-end through Stripe Connect.
| Product | Price | Your commission |
|---|---|---|
| Case files | $149 | (excluded) |
| Inspection Response Record | $497 | $124.25 per unlock |
Every Inspection Response Record your client orders pays $124.25. Cosmetics brands scaling through MoCRA compliance — especially those with multiple product lines and active AE volume — are exactly the profile that orders repeatedly.
We're here before and after the referral.
If a client has a question your playbook doesn't answer, email partner@complianceworxs.com. We'll get back within two business days.
When you're ready to submit your first referral, use the partner portal link in your welcome email. Make sure the client email you submit matches the one they use at checkout — that's how Stripe Connect attributes the commission back to you.