21 CFR Part 11 Compliant ERP & Electronic Batch Records
Purpose-built for API synthesizers, sterile injectables, and solid oral dosage facilities. Eliminate paper batch record errors, automate multi-level electronic signatures, and achieve permanent audit readiness.
Engineered for US FDA, WHO-GMP & EU-GMP Audits
Transform quality assurance from a post-production bottleneck into an automated inline enforcement engine.
Electronic Batch Records (eBMR / eBPR)
Automated bill of materials recipe scale-up with barcode-verified raw dispensing and real-time weigh scale tolerance bounds (+/- 0.01%).
- Tare & gross balance RS-232 telemetry
- Inline critical process parameter (CPP) alerts
Cryptographic Audit Trails
Tamper-evident system event logging capturing every database insert, update, deletion, approval, and rejected sign-off in immutable audit ledgers.
- SHA-256 block hash validation
- Dual maker-checker sign-off enforcement
Integrated LIMS & Sample Stability
Chromatography data system (CDS) integration, automatic OOS/OOT investigation workflows, and multi-zone stability chamber schedule tracking.
- Automated CoA batch release locking
- Zone IVb stability trial management
Frequently Asked Questions
Common questions from QA directors, regulatory heads, and plant executives.
How does Nexova guarantee US FDA 21 CFR Part 11 compliance?
Nexova enforces immutable audit logs with SHA-256 cryptographic chaining, time-stamped biometric electronic signatures (with dual maker-checker authorization), password aging, and automated session timeouts. Every modification records the user identity, UTC timestamp, reason for change, and before/after values.
Does Nexova replace paper-based Batch Manufacturing Records (eBMR)?
Yes. Nexova eBMR guides operators step-by-step through raw material dispensing, staging, granulation, compression, and coating, with real-time weighing scale interlocks and instant deviation logging.
Can Nexova track stability testing and sample quarantine intervals?
Yes. Nexova LIMS schedules accelerated and real-time stability testing pull dates, automatically locking inventory lots from commercial dispatch until all QC chromatography assays pass.
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Nexova is the operating system that process-industry leaders choose when they want a genuine competitive advantage — not just another software implementation.
