GMP & 21 CFR Part 11 Compliant Pharmaceutical ERP Software
Penext Pharma ERP enforces strict regulatory compliance for pharmaceutical formulations, API, and nutraceutical manufacturers. Features digital Batch Manufacturing Records (e-BMR), Batch Packaging Records (e-BPR), electronic signatures, and audit trails.
Designed for US-FDA, WHO-GMP, and Schedule M audited manufacturing plants.
How Penext Solves Critical Industry Bottlenecks
Direct comparison between conventional fragmented methods and Penext's purpose-built digital architecture.
| Pharma Regulatory Area | Standard Business Software | Penext Pharma ERP |
|---|---|---|
| Audit Trails & Signatures | Easily edited without trace | Tamper-proof audit trail with dual-factor electronic signatures (21 CFR Part 11) |
| Raw Material Quarantine | Risk of dispensing unapproved batches | Hard system locks preventing dispensing until QC Certificate of Analysis is approved |
Core Workflows & Functional Architecture
Electronic Batch Manufacturing Records (e-BMR)
Guided dispensing, mixing, granulation, and compression execution workflows.
Stability & Retest Management
Automated stability chamber scheduling and raw material re-test alerts.
Rapid Onboarding & Go-Live Roadmap
Standardized data migration, system pilot, and on-site staff training timeline.
Process Scoping & Master Data
BOM structuring, chart of accounts, vendor master, and item coding migration.
Pilot Setup & Hardware Link
Weighbridge, IoT loggers, barcode scanners, and printer integrations configured.
Floor Staff Training
Hands-on training in Hindi & English for operators, storekeepers, and managers.
Production Go-Live
Parallel run sign-off, live job card generation, and real-time executive dashboard activation.
Everything You Need to Know
Yes. It features cryptographically timestamped audit trails and non-repudiable electronic signatures.
Schedule a Technical Demo for Penext ERP
Speak with our principal enterprise engineers in Bhopal to review your exact requirements.