Batch records reviewed in minutes, not days
Katalyze AI automates the review, exception flagging, and audit trail for pharmaceutical batch records, deviations, and quality checks. Built for FDA 21 CFR Part 11 and GMP environments.
| Parameter | Specification | Actual | Status |
|---|---|---|---|
| Temperature | 22.0-25.0 C | 23.4 C | PASS |
| pH | 6.8-7.2 | 7.1 | PASS |
| Blend Time | 45-60 min | 62 min | REVIEW |
| Sterility | Pass spec | Pending | REVIEW |
| Yield | 95-105% | 98.3% | PASS |
Manual quality review slows your release cycle
Pharmaceutical manufacturers still spend hundreds of hours each month manually combing through batch records, chasing deviations, and preparing audit documentation.
Days lost to manual review
A single batch record can take 6-12 hours of QA time to review, cross-reference, and sign off, bottlenecking product release.
Human error in high-stakes checks
Reviewer fatigue and inconsistent exception criteria create compliance gaps that auditors surface long after the batch ships.
Audit trail gaps under inspection
Paper-based or siloed digital records make it difficult to produce a complete, timestamped audit trail quickly when regulators request it.
Three modules, one quality workflow
Katalyze AI connects your batch records, deviation management, and quality checks into a single AI-assisted review environment.
Batch Records
AI reviews each parameter against specification, flags out-of-range values, and generates a complete exception summary with supporting evidence. Reviewers approve, not transcribe.
Explore Batch RecordsDeviations
Capture, classify, and route deviations automatically. AI suggests root-cause categories and corrective action templates based on your historical deviation library.
Explore DeviationsQuality Checks
Schedule, execute, and document in-process and release testing workflows. AI cross-references results against master specifications and prior batch trends.
Explore Quality ChecksEarly-access sites report measurable gains
"The AI review catches parameter trends we would have missed doing manual lookups. Our QA team spends their time on actual judgment calls now, not data entry verification."
"Deviation routing used to require three email threads before the right team even saw the record. Katalyze routes it correctly on the first pass and attaches the relevant precedents automatically."
Metrics based on pilot data across early-access manufacturing sites. Individual results vary by site complexity and batch type.
Designed for regulated manufacturing environments
Katalyze AI is built to support the documentation, traceability, and electronic signature requirements of regulated pharmaceutical and biotech operations.
Simple, module-based pricing
Start with one module and expand as your quality operations grow.
For single-site manufacturers up to 150 batches per month.
- All 3 modules
- Up to 150 batches/month
- Up to 5 QA users
- Standard IQ/OQ/PQ documentation
- Email support
For multi-product facilities with higher batch volume and dedicated QA teams.
- All 3 modules
- Up to 500 batches/month, up to 3 sites
- Unlimited QA users
- Full IQ/OQ/PQ + Quality Agreement
- Priority support + CSM
For multi-site manufacturers with complex GMP environments and dedicated IT requirements.
- Everything in Professional
- Multi-site deployment
- Private cloud / on-premises option
- Custom SLA
- Dedicated validation support
See Katalyze AI on your batch data
Book a 30-minute demo and we will walk through how automated review would work against a sample of your actual batch record structure.
No commitment required. Typically a 2-week onboarding from contract to first live review.