MoCRA registration deadlines have passed. ISO 22716 audits are real. Batch Buddy gives cosmetics and personal care manufacturers the compliance infrastructure to stay audit-ready, without the enterprise price tag.
No credit card required • First batch record in 30 minutes
If any of these sound familiar, Batch Buddy was built for you.
Facility registration, product listing, Responsible Person documentation, and 15-day adverse event reporting, all landing on small quality teams with no digital infrastructure.
No sequential batch record enforcement. Missing deviation logs. Training records in spreadsheets. Auditors find these gaps, and they write them up.
MoCRA requires FDA notification within 15 business days of a serious adverse event. Without traceable batch data, you're guessing which product was involved.
During a mock or real recall, you can't quickly answer which customers received product from a specific ingredient lot. That's a regulatory crisis.
No master/draft control. No audit trail for formula changes. Operators pull the wrong version and no one knows until the batch fails QC.
Untracked yield losses and manual rework calculations mean you don't know your true cost per unit, or which batches are quietly losing money.
Built for the specific compliance requirements of cosmetics and personal care manufacturing.
Sequential, tamper-evident batch records that enforce every step. Operators can't skip checkpoints, sign on behalf of others, or submit incomplete records. HMAC hash-chained from first entry to QA release.
Trace any ingredient lot forward to finished goods and customers within minutes. Bidirectional recall simulation gives you a signed drill report capturing FSMA 204 Key Data Elements.
Store Responsible Person records, product listing support documents, and adverse event audit trails. Indexed by SKU and batch for rapid FDA retrieval.
9-state CAPA lifecycle with root cause, corrective action, preventive action, and effectiveness verification. 3-phase OOS investigation with deviation-to-CAPA workflow.
Import supplier COAs via AI-powered OCR (GPT-4o vision). Every imported COA is HMAC-signed for tamper evidence, giving you a defensible chain of custody from supplier to shelf.
Automated First-Expired-First-Out lot allocation. Expired lots are blocked from production automatically. Every lot is tracked from receipt to depletion.
Scale formulas, update costs, log deviations, and query inventory via natural language. Every Copilot action is written to the cryptographic audit trail, fully defensible.
Live landed cost and yield variance visibility per batch. Know your true cost per unit before a run, and see exactly where losses occurred after.
Alignment reference, not a certification document.
| ISO 22716 Section | Batch Buddy Features | Coverage |
|---|---|---|
| §4 Personnel | Training Records · Role-based access · Audit trail · Staff activity logs | Full |
| §5 Premises | Room Tracking module · Facility logs | Strong |
| §6 Equipment | Equipment status in OOS investigations | Partial |
| §7 Raw Materials | Supplier management · COA import (OCR) · HMAC-signed COAs · Lot traceability | Full |
| §8 Production | Electronic batch records · YieldGuard · Formula/BOM management · FSMA 204 traceability | Full |
| §9 Finished Products | Batch release workflow · COA generation · HMAC-signed release records · Retention policy | Full |
| §10 Quality Control | CAPA+OOS module · Deviation tracking · OOS investigation · Spec management | Full |
| §11 Documentation | Hash-chain audit proof · 21 CFR Part 11 controls · Tamper-evident records | Full |
| §12 Internal Audits | CAPA module · Audit trail · Deviation-to-CAPA workflow | Strong |
| §13 Subcontracting | Supplier qualification records · COA management for CMOs | Partial |
| §14 Complaints & Recalls | Bidirectional recall simulation · CAPA integration · FSMA 204 chain | Full |
| §15 Change Control | Audit trail · Formula version history (master/draft) | Partial |
| §16 Outsourced Testing | COA import & management · OOS tracking via CAPA+OOS | Strong |
| §17 Stability | Product specifications · Batch records | Partial |
| §18 Validation | Validation Pack (235+ automated regression tests) · Validation documentation | Partial |
This matrix is an alignment reference, not a certification document.
A practical playbook covering MoCRA deadlines, the full ISO 22716 GMP compliance matrix, a 10-point self-assessment checklist, and a 90-day audit readiness plan. Written for cosmetics and personal care manufacturers.
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An honest look at the options cosmetics manufacturers typically evaluate.
| Feature | Batch Buddy | Paper / Excel | Generic ERP (e.g. NetSuite) |
Aptean Process Manufacturing |
|---|---|---|---|---|
| Price tier | $149–$1,499/mo | ~$0 (hidden labor cost) | $3,000–$10,000+/mo | $5,000–$20,000+/mo |
| Implementation time | Days to weeks | Ongoing manual effort | 6–18 months | 6–12 months |
| MoCRA-ready out of the box | ✓ Yes | ✗ No | ~ Requires customization | ~ Partial, add-ons |
| ISO 22716 GMP module | ✓ Native (7 full sections) | ✗ No | ~ Configurable only | ✓ Yes |
| Bidirectional Recall Sim | ✓ Built-in, HMAC-signed | ✗ No | ✗ Not standard | ~ Limited |
| AI Copilot (natural language) | ✓ GPT-4o powered | ✗ No | ✗ No | ✗ No |
Pricing and feature data based on publicly available information as of 2026. ✓ = native capability; ~ = partial/configurable; ✗ = not available.
No enterprise contract. No 12-month implementation. Start your free trial today and run your first ISO 22716-compliant batch record within 30 minutes.
No credit card required • Cancel anytime • Questions? support@batchbuddy.ai