ERP for Biotech & Biopharma
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.
Compliance Gaps and
Traceability Blind Spots
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.
Regulatory Audit Trails
Electronic records with full user attribution, timestamps and change tracking on every transaction, so your audit trail is complete from day one without a separate compliance system.
Lot Genealogy & Recall
Complete forward and backward lot traceability from raw material receipt through finished goods distribution. Execute targeted recalls in minutes, not days.
R&D Batch Management
Seamless transition from lab-scale R&D batches to production-scale manufacturing with formula versioning, stability tracking, and scale-up documentation.
Quality & GMP Controls
In-process quality checkpoints with hold-and-release integrated directly into inventory and production, so a failed check stops the run until someone reviews and releases it.
Regulatory Readiness at a Glance
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.
Pain Points We Solve
These are the operational bottlenecks biopharma teams face daily — and exactly how ianaiERP eliminates them.
The Pain Point
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
The Pain Point
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
The Pain Point
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
The Pain Point
Role-based access and data integrity expectations
Unrestricted access invites accidental edits and weakens audit readiness.
Roles/permissions and audit-friendly activity logs
The Pain Point
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
The Pain Point
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