SigzenPHARMA

Yes. SigzenPHARMA is fully compliant with 21 CFR Part 11. It includes electronic signatures, audit trails, and role-based access control, ensuring your pharmaceutical business meets GMP and FDA compliance requirements for digital documentation and quality systems.

SigzenPHARMA supports multi-company and multi-plant ERP configurations, allowing centralized control over batch manufacturing scheduling, inventory management, and procurement workflows across multiple sites.

Yes. It offers seamless integration with LIMS (Laboratory Information Management Systems) and digital weighing systems using REST APIs and plug-ins, enabling automated test data capture and lab process synchronization.

Absolutely. The system provides audit-ready reports, digital BMRs, and quality logs, all exportable for regulatory agencies like USFDA, MHRA, WHO-GMP, improving regulatory inspection readiness and compliance transparency.

SigzenPHARMA includes complete SOP-based training, IQ/OQ/PQ validation templates, and computer system validation (CSV) documentation, helping your QA teams validate systems and educate personnel efficiently.

Yes. With the Pharma ERP Finance & Batch Costing Module, you can monitor material costs, labor charges, energy consumption, and cost variance for each production batch—fully integrated with GST compliance and multi-level approval workflows.

It offers batch-wise stock management, expiry and retest tracking, and cold chain monitoring, supporting traceability from raw material to finished goods dispatch—crucial for pharma compliance and product recalls.

Yes. Through the HRMS and Training Records module, it enables training matrix tracking, GMP-based role assignments, and shift bio-attendance logging, ensuring workforce compliance and audit preparedness.

The system includes customizable QC sampling templates, in-process checks, and CAPA tracking, helping ensure consistent product quality and regulatory compliance across all manufacturing stages.

Yes. SigzenPHARMA can be deployed on the cloud and accessed via mobile ERP dashboards, providing real-time visibility into production, inventory, and quality metrics, even while on the move.

Yes. It includes all required features like audit trails, electronic signatures, and access controls.

Yes. We provide SOP-aligned user training, IQ/OQ/PQ templates, and assistance.GMP-compliant documentation