noxVIEW Product
BMR
Batch Manufacturing Records
Paperless electronic batch records that ensure FDA 21 CFR Part 11 compliance, reduce documentation errors, and accelerate batch release.
Key Features
Electronic batch record creation and execution
Digital signatures with 21 CFR Part 11 compliance
Automated deviation detection and CAPA workflow
Material consumption tracking and reconciliation
In-process quality checks and sampling management
Batch genealogy and full traceability
Benefits
Faster Batch Release
Eliminate paper review bottlenecks — reduce batch release time from days to hours with automated review-by-exception.
Zero Documentation Errors
Mandatory fields, validation rules, and electronic signatures eliminate handwriting errors and missing entries.
Regulatory Compliance
Built-in FDA 21 CFR Part 11, EU Annex 11, and GAMP5 compliance with complete audit trail.
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