One platform for every quality workflow
Batch record review, deviation management, and quality checks: three modules that connect the full manufacturing quality lifecycle. Each works independently; together they eliminate the documentation gaps that cause inspection findings.
Figures from early-access pilot sites. Results vary by batch complexity and product type.
Automated review for every batch record
AI spec comparison, exception classification, and reviewer packets built in minutes.
Batch record review is the highest-volume, most repetitive task in pharmaceutical quality. Katalyze AI reads your batch record against the approved master batch record specification, flags line-item exceptions, classifies each by type and potential impact, and delivers a structured reviewer packet that QA can act on immediately.
- Spec comparison against master batch record
- Exception classification by type and regulatory relevance
- Structured reviewer packet with traceability chain
- Electronic signature workflows designed to meet 21 CFR Part 11 requirements
Structured deviation management from intake to closure
AI classification routes each deviation to the right owner with the right priority, automatically.
Manual deviation intake creates documentation inconsistency, routing delays, and CAPA timeline overruns. Katalyze AI classifies each reported deviation by type, severity, and product impact, routes to the assigned owner, and tracks the full investigation through closure with an immutable audit trail.
- AI-assisted deviation classification on intake
- Automated routing to CAPA owner
- SLA tracking and escalation triggers
- Full investigation-to-closure audit trail
Scheduled checks that never slip through
Assign, track, and log every quality check with a complete audit trail from schedule to closure.
Scheduled and assigned
Quality checks are scheduled from product master data and automatically assigned to the appropriate QA personnel based on site and product type.
Completed and logged
Check completion is logged with timestamp, operator, and result. Exceptions trigger an immediate classification step before the record closes.
Always audit-ready
Every check produces a signed, timestamped record. No paper, no spreadsheet, no end-of-quarter reconstruction.
Designed for validated GMP environments
Katalyze AI integrates above your existing systems, requiring no MES or LIMS replacement.
Most quality teams can not afford to replace their MES, LIMS, or ERP systems to get AI-assisted review. Katalyze AI sits above those systems: reading data from your existing infrastructure, running AI analysis, and writing results back as compliant electronic records. The existing systems keep doing what they do; Katalyze AI adds the review and analysis layer.
- Integrates via API or file-based exchange
- Supports common MES formats and batch record structures
- Validation documentation provided at contract signing
- SOC 2 Type II in progress, data encrypted at rest and in transit
See the full platform against your batch data
Book a demo and we will walk through all three modules against a sample of your batch record and deviation history. No data migration required to start.
Typical onboarding: 2 weeks from contract to first live batch review.