Built for cosmetic and personal-care manufacturers under MoCRA, where safety substantiation, supplier COAs, and every formula change have to stay traceable, and hold up in a retailer audit or an FDA inquiry.
Built for cosmetic and personal-care manufacturers
Incumbents track a folder of PDFs. Unifize reconstructs the decision trace across every function a formula or supplier change touched, and every safety claim it rests on.
The reconstruction always lands on someone. Find your seat, and see what you own when the trace has to hold up at a retailer audit or an FDA inquiry.
Every formula and supplier decision stays reconstructable.
Formula changes and material dispositions move on one accountable thread.
Facility registration, product listing, and the EU Product Information File stay current per SKU.
Safety substantiation, adverse event reports, and hazard analyses are captured where they happen.
Formula and packaging changes move fast with their rationale and stability data sealed to the record.
Each runs with MoCRA, ISO 22716 and the EU PIF built in. Start with the one that costs you most.
From the executed batch record to a substantiation file that holds at the retailer audit.
Ingredient COAs captured and tied to the lots they clear, not chased at receipt.
Consumer adverse events triaged against the MoCRA clock, hazard analysis attached.
Facility registration, product listing and claims kept current as formulas change.
Unifize sits alongside the formula PLM, ERP, QMS, and ingredient-compliance tools you already run. It replaces the ungoverned channels where the decision trace goes missing, not your systems of record.
Every approval is captured as an attributable, time-stamped electronic signature, so the safety substantiation trail is a record a retailer or the FDA can follow, not a reconstruction.
Facility registration and product-listing maintenance, adverse event reporting, and safety substantiation completeness are walked through with your team before anything touches a controlled record.
Enforcement and retailer deadlines, not internal outcomes. Each one routes to the process that answers it and the team that owns the response.
Routes to Safety Substantiation File · owned by Quality
Routes to Supplier COA Management · owned by Supplier Quality
Routes to Product Information File · owned by Regulatory
$1.6Mto$16.9M
Applechem, which makes functional ingredients for cosmetics and personal care, on supplier validation, change control, approvals, CAPA with contract manufacturers and audits. Figures are as stated on film.
ApplechemWilson LinRaw materials validated with vendor audits and approvals
ApplechemWilson LinNo more asking if a supplier sent the document back
ApplechemWilson LinChange control requests cut from months to two weeks
ApplechemWilson LinApprovals that ran up to 8 months now take about two weeks
ApplechemWilson LinCorrective actions down from months to a few weeks
ApplechemWilson LinAudit evidence found in minutes, not 30 of searchingPick a formula or supplier change you could not replay at the last retailer audit. We will reconstruct it live.
