Support regulated, multi-stage processes—from R&D batches to full-scale manufacturing.
Your ERP must support regulated, multi-stage processes—from R&D batches to full-scale manufacturing. ianaiERP provides work order workflows that log every step, instrument reading, and inspection. Compliance records (FDA, GMP, ISO) are digitally captured, supporting traceability and audit readiness. R&D inputs, cost tracking, and production run data converge in a unified platform that scales with volume and geography. User roles and access controls enforce data integrity. Feature-wise, the system automatically generates electronic batch records, deviation logs, and lot reconciliation reports.
IanaiERP's Compliance & Traceability Intelligence gives biopharma companies end-to-end lot genealogy, automated FDA/GMP audit trails, and real-time quality oversight — so you can prove compliance instantly instead of scrambling before every inspection.
Automated 21 CFR Part 11-ready electronic records with full user attribution, timestamps, and change tracking. Every transaction is audit-ready from day one.
Complete forward and backward lot traceability from raw material receipt through finished goods distribution. Execute targeted recalls in minutes, not days.
Seamless transition from lab-scale R&D batches to production-scale manufacturing with formula versioning, stability tracking, and scale-up documentation.
Built-in quality checkpoints, CAPA workflows, and deviation management integrated directly into your inventory and production processes.
Full lot genealogy enables targeted recalls in under 30 minutes, reducing recall scope by up to 90%.
Automated audit trails eliminate manual record-keeping and reduce FDA inspection preparation time dramatically.
Integrated quality holds and release workflows prevent non-conforming material from reaching production or distribution.
R&D-to-production handoff with formula versioning cuts tech transfer timelines and preserves institutional knowledge.
These are the operational bottlenecks biopharma teams face daily — and exactly how ianaiERP eliminates them.
Multi-stage batch processes and precise work instructions
Handoff errors between stages lead to failed batches and wasted raw materials.
Work orders with staged operations, inputs/outputs, and notes
Strict documentation needs across R&D and production
Outdated or missing documents risk audit findings and regulatory delays.
Document versioning and attachments for protocols and results
Lot genealogy and controlled material usage
Inability to trace a lot backwards means recalls become company-wide instead of targeted.
Lot tracking and material issues/returns to maintain genealogy
Role-based access and data integrity expectations
Unrestricted access invites accidental edits and weakens audit readiness.
Roles/permissions and audit-friendly activity logs
Cost tracking from development batches to scale-up
Hidden R&D costs surface too late, making scale-up pricing guesswork.
Unified cost capture across R&D runs and production batches
Supplier qualification and incoming material control
Unqualified suppliers or uninspected raw materials slip into batches, risking entire production runs.
Supplier management with approved vendor lists, incoming QC checks, and COA attachments per receipt