Pricing
Straightforward pricing for quality teams
Three tiers based on batch volume and site count. All tiers include all three modules and compliance documentation. No per-user fees.
Starter
For single-site manufacturers up to 150 batches per month.
$2,400
/month
$1,920
/month, billed annually
- Up to 150 batches/month
- 1 manufacturing site
- All 3 modules (Batch Records, Deviations, Quality Checks)
- Up to 5 QA users
- Records designed to meet 21 CFR Part 11 requirements
- Standard IQ/OQ/PQ documentation
- Email support (2 business day response)
- 99.5% uptime SLA
Most popular
Professional
For multi-product facilities with higher batch volume and dedicated QA teams.
$5,800
/month
$4,640
/month, billed annually
- Up to 500 batches/month
- Up to 3 manufacturing sites
- All 3 modules
- Unlimited QA users
- Records designed to meet 21 CFR Part 11 requirements
- Full IQ/OQ/PQ + Quality Agreement
- API access for MES/ERP integration
- Deviation trend analytics
- Priority support (4-hour response)
- 99.9% uptime SLA
Enterprise
For large CMOs, contract manufacturers, and multi-site global operations.
Custom
pricing
Custom
annual pricing
- Unlimited batches
- Unlimited sites
- All 3 modules
- Unlimited QA users
- Custom compliance documentation
- On-premise or private cloud deployment
- Dedicated customer success manager
- 24/7 support with named contacts
- Custom SLA terms
- HIPAA BAA and custom DPA available
Feature comparison
See what is included in each tier
| Feature | Starter | Professional | Enterprise |
|---|---|---|---|
| Platform Modules | |||
| Batch Records module | |||
| Deviations module | |||
| Quality Checks module | |||
| Usage Limits | |||
| Batches per month | Up to 150 | Up to 500 | Unlimited |
| Manufacturing sites | 1 | Up to 3 | Unlimited |
| QA users | Up to 5 | Unlimited | Unlimited |
| Compliance and Validation | |||
| 21 CFR Part 11-aligned records | |||
| IQ/OQ/PQ documentation | Standard | Full + QA Agreement | Custom |
| Annex 11 documentation | |||
| Integration and API | |||
| MES/ERP API integration | |||
| CSV/file-based import | |||
| On-premise deployment | |||
| Support and SLA | |||
| Support response time | 2 business days | 4 hours | 24/7 named contacts |
| Uptime SLA | 99.5% | 99.9% | Custom |
| Dedicated CSM | |||
Frequently asked questions
Questions about pricing
No. Starter includes up to 5 QA users; Professional and Enterprise include unlimited users. We do not charge per user because quality teams should be able to add reviewers, approvers, and investigators without worrying about per-seat costs escalating.
A batch is counted when a batch record enters the review workflow. Batches that are rejected and resubmitted within the same cycle count as one batch. Trial runs, training batches, and batches reviewed in a validation environment do not count toward your monthly limit.
We will notify you when you reach 80% of your monthly limit and discuss upgrading your tier. We will not abruptly block batch reviews at the limit. Overages are billed at a per-batch rate for the remainder of that billing cycle.
Professional includes the full IQ/OQ/PQ documentation package, the Katalyze AI Quality Agreement (required under EU Annex 11 and recommended for 21 CFR Part 11 regulated environments), the GAMP 5 risk assessment, and change notification procedures. This is provided at contract signing.
Upgrades are available at any time and are prorated. Downgrades take effect at the next renewal date. Contact your account manager or our sales team to discuss a tier change.
We offer a structured proof of concept engagement for Professional and Enterprise prospects. During the POC, we configure Katalyze AI against a set of your actual batch records and deviation history under a limited-term NDA. Contact our sales team to discuss POC terms.
Get Started
Not sure which tier fits?
Talk to our team. We will ask you about your batch volume, site count, and quality team size, and recommend the right tier, including whether a POC makes sense first.