Cosmetics & Personal Care
AI for cosmetics and personal care quality
MoCRA turned cosmetics recordkeeping from a best practice into a legal obligation with FDA record access attached. Litewave reads your batch documentation, raw material certificates and safety files, checks them against your specifications and against ISO 22716, and keeps the evidence assembled.
The rulebook, as it stands today
MoCRA
- The Modernization of Cosmetics Regulation Act, the first substantive expansion of FDA authority over cosmetics since 1938
- Facility registration and product listing through FDA Cosmetics Direct
- Adverse event reporting, with serious adverse events reported to FDA and related records retained
- Adequate substantiation of safety, with records maintained, for every cosmetic product
- FDA record access where there is a reasonable belief a product or ingredient is adulterated and presents a threat of serious adverse health consequences
- Good Manufacturing Practice regulations directed by rulemaking. These are not yet final, so ISO 22716 remains the operative standard today
ISO 22716
- The GMP guideline most manufacturers and most retail customers actually hold you to
- Personnel, premises, equipment, raw and packaging materials
- Production, finished products, and the quality control laboratory
- Treatment of out-of-specification product, deviations, complaints and recalls
- Change control, internal audit and documentation
Selling into the EU
- EU Regulation 1223/2009, requiring a Responsible Person
- A Product Information File including the Cosmetic Product Safety Report
- CPNP notification
- GMP compliance, with ISO 22716 as the harmonized route
- The ingredient restriction Annexes
US labeling and state law
- 21 CFR Parts 700, 701 and 740 for cosmetic labeling and specific ingredient provisions
- The Fair Packaging and Labeling Act
- State requirements including California ingredient and disclosure law
- State ingredient restrictions change frequently, so treat your market list as a living document
If a contract manufacturer makes your product, the obligation is still yours
MoCRA puts safety substantiation and adverse event records on the responsible person, not on whoever ran the filling line. A certificate in a folder from your contract manufacturer is not the same as having reviewed what they actually recorded.
Litewave reads your contract manufacturer batch documentation the same way it reads your own, so oversight becomes a review you actually perform rather than a certificate you file.
The documents this actually touches
Batch manufacturing records and compounding sheets. Bulk and filling records. Master formulas and specifications. Raw material and packaging component specifications and CoAs. Water system monitoring. Microbiological testing and preservative efficacy results.
In-process checks including pH, viscosity, specific gravity, appearance and fill weight. Cleaning, changeover and line clearance records. Equipment logs. Finished product release records. Stability and packaging compatibility studies. Safety substantiation files and toxicological assessments. Product Information Files. Adverse event, complaint and recall records. Label and artwork approvals.
What Litewave checks here
Batch documentation
- Batch documentation follows the master formula, with every raw material, lot and quantity matched
- Theoretical against actual reconciled
- In-process checks recorded and in specification, with instrument calibration current
- Water system monitoring in limit for the manufacturing window
- Signatures and verification steps complete on every step that requires them
Raw materials
- Raw material CoAs checked against your approved specification
- Microbiological limits, heavy metals and preservative content verified
- Restricted or prohibited ingredients screened for every market you ship to
- Supplier approved and qualification in date
Microbiological and stability
- Preservative efficacy and microbiological testing present and passing for the batch or the qualified family
- The challenge test tied to the formula as it exists now, not as it existed two reformulations ago
- Finished product release results complete and within specification before release
- Stability and packaging compatibility data current for the presentation being shipped
Safety file and labeling
- The safety substantiation file present and current for the formula as it exists today
- The file references the correct raw material data
- Label and artwork match the approved version, including ingredient declaration in INCI order and net contents
- Adverse event records complete, with reportable events identified and their reporting clock started
Your workflow, mapped
What your team does today
Batch documentation review and finished product release
What Litewave automates
Batch Review & Release
What your team does today
Deviations, out-of-specification product, complaints, recalls
What Litewave automates
Deviation Investigations
What your team does today
Raw material CoAs and contract manufacturer oversight
What Litewave automates
Supplier Quality & CoA Review
What your team does today
Complaint and adverse event trending, management review
What Litewave automates
Quality Analytics
Where our evidence comes from
Litewave was built in pharmaceutical manufacturing, which is the strictest records regime in regulated industry. At the world’s largest sulfamethoxazole producer, batch disposition time fell by 85% across 100 to 150 page paper batch records, with no eBPR migration and no SOP changes.
That matters for your site because the artifacts are structurally the same as yours: a master record defining what should happen, an executed record saying what did, in-process checks, supplier certificates, deviations, and a release decision somebody has to sign and defend. The engine that reconciles a 150 page executed record against a master record and a specification does not care what the product is. What changes is the rulebook it checks against, and that is configuration.
Your ISO 22716 batch manufacturing record checks are configured against your specifications and your governing standard, by the team that built the pharmaceutical deployments.
Bring one real record
A ISO 22716 batch manufacturing record, or a stack of supplier certificates. Something you actually execute, not a sample.
We run a scoped evaluation
We configure the checks against your specification and your governing standard, run them on your records, and show you every finding with the source page cited.
You compare against your own reviewer
Your team reviews the same records the way they always do. You see where we agree, where we disagree, and where we found something they did not. Then you decide.
Questions we get asked
Are MoCRA GMP requirements in force?
MoCRA directs FDA to establish cosmetics GMP through rulemaking, and that rule is not yet final. ISO 22716 is what the industry and your retail customers hold you to today, and it is what we configure against. When the GMP rule lands, your checks get updated, not rebuilt.
We use contract manufacturers for everything. Does this still apply?
Especially then. The safety substantiation and adverse event obligations stay with you regardless of who runs the line, so the question is whether you are reviewing what your manufacturer recorded or just filing their certificate.
What evidence do you have that this works?
A production deployment in pharmaceutical manufacturing, running against a records regime considerably stricter than ISO 22716, with batch disposition time down 85%. Ask us to run a scoped evaluation on your own batch documentation and judge it on your own records.
Related
Built for validated environments
Your data stays where your auditors expect it
Deploy in your environment
Your cloud, your data center, on the plant floor, or fully air-gapped. The same agents run identically in all four.
Your data never trains our models
Documents are never sent to third-party AI providers and are never used to train any model, ours or anyone else’s.
21 CFR Part 11
Electronic records, electronic signatures and complete audit trails on every action, built to ALCOA+ data integrity principles.
EU GMP Annex 11
Meets European GMP expectations for computerised systems used in regulated manufacturing.
Evidence on every flag
Every extraction, check and recommendation links back to its source page. Nothing asserted is unverifiable.
Human in the loop by design
Agents propose, qualified people approve. Litewave never dispositions a batch on its own.
See it run on one of your own records
Bring something real. We will show you what Litewave finds in it and what it cites as evidence.