Nutraceuticals & Dietary Supplements
AI for dietary supplement and nutraceutical quality
21 CFR Part 111 asks you to prove three things on every batch: that you followed the master manufacturing record, that you verified what came in the door, and that the finished product meets its specifications. Litewave checks all three against the records you already keep.
What Part 111 actually obliges
Master and batch records
- A written master manufacturing record for each unique formulation and batch size, under 111.205 and 111.210
- Specifications at each point where control is necessary
- A batch production record for every batch that accurately follows the MMR, under 111.255 and 111.260
- The identity and weight of each component, in-process controls, and the initials of the person performing and the person verifying each step
Incoming materials
- At least one appropriate test or examination to verify the identity of every incoming dietary ingredient, under 111.75
- For other components, either testing or documented reliance on a qualified supplier certificate of analysis
- Supplier qualification that is established and periodically confirmed rather than assumed
- Rejected material handled and recorded
Quality control unit
- Review and approval of records before release
- Material review and disposition decisions documented
- Finished product specifications and testing sufficient to show the product meets them
- Reserve samples retained and recorded
Adjacent obligations
- FSMA facility registration, with FSVP applying to importers
- Serious adverse event reporting and product complaint handling under Subpart O
- DSHEA framing for labeling and claims, and New Dietary Ingredient notification
- Third-party programs that drive real documentation load, including NSF GMP registration and USP Verified
The documents this actually touches
Master manufacturing records. Batch production records. Component and ingredient specifications. Incoming identity test results. Supplier qualification files and CoAs. In-process control records. Equipment and cleaning logs. Weighing and dispensing records.
Blending, encapsulation, tableting and coating records. Packaging and labeling records including label reconciliation. Finished product specifications and CoAs. Stability data. Reserve sample records. Complaint and returned product records. The quality control unit review and disposition record.
What Litewave checks here
Against the master manufacturing record
- The batch production record accurately follows the current MMR, step by step
- In-process specifications and controls present and met
- Actual component identity, supplier, lot and weight for every ingredient matched to the MMR formula and the receiving record
- Theoretical against actual yield reconciled at each stage, with variances explained
Incoming ingredient verification
- Every incoming dietary ingredient has a documented identity test result on file
- Every other component has either a test result or a qualified supplier certificate, with the qualification current
- Certificate results reconciled against your own incoming testing
- Supplier approved for this material and this receiving site
Signatures and verification
- Initials of the person who performed and the person who verified present on every step that requires them
- Dated, and not the same person where separation of duties is required
- Corrections made in line with good documentation practice
- The quality control unit review and disposition documented before release
Finished product and labeling
- Test results present for every finished product specification, within limit, traceable to analyst raw data
- Overage, potency and label claim reconciliation: does the batch as executed support what the label declares
- Label and packaging reconciliation, with labels issued, used, damaged and destroyed accounted for
- Reserve sample retained and recorded
Part 111 findings cluster in three places
No master manufacturing record. Batch records that do not actually follow the one that exists. No identity testing on incoming ingredients.
Those are exactly the three things a record-reading system can check on every batch, rather than on the batches somebody had time to look at.
Your workflow, mapped
What your team does today
Batch production record review and QC unit disposition
What Litewave automates
Batch Review & Release
What your team does today
Deviations, complaints and returned product investigations
What Litewave automates
Deviation Investigations
What your team does today
Incoming ingredient identity and supplier CoA qualification
What Litewave automates
Supplier Quality & CoA Review
What your team does today
Records review, complaint trending, specification performance
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 Part 111 batch production record checks are configured against your specifications and your governing standard, by the team that built the pharmaceutical deployments.
Bring one real record
A Part 111 batch production 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
Does Litewave replace incoming identity testing?
No, and under Part 111 it cannot. An identity test on each incoming dietary ingredient is required regardless of what a certificate says. Litewave reconciles your test result against the certificate and flags where a test is missing entirely.
Can it help with label claim substantiation?
It reconciles the batch as executed against what the label declares, including overage and potency. It does not do claims substantiation in the DSHEA sense, and we are not going to pretend otherwise.
We are a contract manufacturer with constant formulation changes.
That is the case where template-based systems struggle most, because every new formulation needs its own validated template. Litewave reads the record against whichever MMR is current, so a new formulation is live when its MMR is.
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.