Batch record review in hours, not days
Automated spec comparison against the master batch record, structured exception classification, and compliant reviewer packets that give QA exactly what they need to act.
Manual review costs 2-3 days per batch
Batch record review is repetitive, document-intensive, and prone to missed exceptions when done at volume.
A typical pharma manufacturer processes dozens to hundreds of batches per month. Each batch record review requires a QA professional to compare every logged value against the approved specification, document any variance, classify each exception, and route it appropriately. At 3 to 8 hours per record, this is the largest single time sink in pharmaceutical quality operations.
Beyond the time cost, manual review at volume creates inconsistency risk: different reviewers classify the same variance differently, and exceptions in high-line-count records get missed when reviewer attention fades. Those inconsistencies become findings in FDA 483s and warning letters.
From upload to reviewer packet
Four steps, fully automated except the final QA sign-off.
Ingest
Batch records are ingested via API from your MES or ERP, or uploaded as PDF or structured file. Katalyze AI normalizes the format against your registered master batch record template.
Spec comparison
Each logged value is compared against the approved specification, including upper and lower limits, nominal values, and conditional requirements. No line is skipped.
Exception classification
Variances are classified by type (out-of-spec, out-of-trend, documentation error, equipment deviation) and by potential regulatory relevance. Each gets a suggested disposition.
Reviewer packet
The structured reviewer packet groups all exceptions with full traceability: master spec reference, as-manufactured value, classification rationale, and suggested action. QA reviews and signs electronically, triggering any required CAPA workflow.
Built for 21 CFR Part 11 and Annex 11
Every step of the review process produces a compliant electronic record with full audit trail.
Electronic signatures
QA review and approval captured as electronic signatures designed to meet 21 CFR Part 11 requirements, with identity verification and non-repudiation controls.
Immutable audit trail
Every action, modification, and approval is logged in an immutable audit trail. No record can be altered without detection and attribution.
Validation documentation
IQ/OQ/PQ documentation and validation protocols are provided at contract signing, reducing your validation timeline significantly.
See Batch Records against your own data
We will pull a sample of your batch record format in a discovery call and show you exactly what the AI review and exception classification looks like against your data.