Better Traceability, Validation, Quality Management, Audit-Readiness, Lot Control, Compliance, Serialization, GxP Alignment, Regulatory Control, Scalability, Everything...
NetSuite Goes Better With BSP
For MedDev, BioTech and Pharma

What’s Included in the eQMS Bundle?

DCO (Document Control) - Control your quality documents with confidence.
DCO helps teams manage SOPs, work instructions, and controlled documents with version tracking, approval workflows, and complete audit history - so everyone is working from the current, approved version.

Training - Make training completion visible, enforceable, and audit-ready.

Track role-based training requirements, assign due dates, and maintain records of completion tied to specific procedures or document revisions. When a document changes, the right people can be retrained automatically.

CAPA (Corrective and Preventive Actions) - Turn quality issues into measurable improvements.

CAPA workflows help teams investigate root causes, assign corrective actions, track preventive actions, and verify effectiveness - all within NetSuite. Every step is documented and traceable for internal and external audits.

NCR (Non-Conformance Report) - Capture non-conformances early and resolve them systematically.

NCR enables teams to log quality events tied to receiving, production, or post-market issues, route them for review, and track disposition decisions with complete visibility and accountability.

Customer Complaints - Close the loop between customer feedback and quality improvement.

Customer complaints can be logged, classified, investigated, and linked directly to CAPAs, NCRs, and affected products or lots - giving your team a complete view of issue history and response actions.

What’s Included in the Medical Device & BioTech Bundle?

Lot Status Control & Enforcement

Maintain strict control over inventory status throughout its lifecycle. Role-based permissions restrict who can change lot status, while automated controls prevent unauthorized updates - including bin transfers - ensuring inventory integrity at all times.

Automatic Quarantine & Expiration Controls

Prevent non-compliant inventory from entering operations. Lots can default to quarantine upon receipt or production, and expired lots are automatically moved to quarantine status - reducing risk and enforcing compliance without manual intervention.

Shipment Restrictions for Unapproved Lots

Ensure only approved inventory reaches customers. System controls prevent unapproved or non-compliant lots from being picked, packed, or shipped - protecting against regulatory violations and costly recalls.

Inventory Visibility by Lot and Status

Gain real-time visibility into inventory across locations. View on-hand and available quantities by item, lot, and status to support planning, quality decisions and audit readiness.

Barcode Labeling for Lot Traceability

CImprove accuracy and efficiency with standardized labelingh. Generate internal bardcode labels for items and lots to support scanning, tracking, and operational consistency across warehouse and production environments.

Vendor Lot Approval Controls

Stop unapproved inventory before it impacts financials or operations. Automated alerts notify Accounts Payable if vendor bills include lots that have not been approved, ensuring alignment between procurement, quality, and finance.

Approved Country Controls (Regulatory Distribution)

Control where products can be sold based on regulatory approval. Restrict shipments by country at the item level to ensure compliance with regional regulations and market approvals.

Standard Cost Management Across Locations

Maintain financial accuracy in complex environments. Manage standard costing across multiple locations to support consistent reporting, margin analysis, and operational control.

Why It Matters

Medical Device and BioTech Companies cannot rely on manual processes or loosely controlled systems when managing inventory. Every lot must be tracked, approved, and handled according to strict regulatory and operational standards.

BSP's Bundle Ensures That:

• Inventory status is controlled and enforceable - not advisory

• Only compliant products move through the supply chain
• Quality, operations, and finance remain aligned
• Global Distribution follows regulatory constraints
• Traceability is maintained at every step.

Designed for Regulatory Controls

This bundle is purpose-built for:

• Medical Device Manufacturers

• BioTech and BioPharma Companies
• Contract Manufacturers (CDMOs)
• Companies Operating Under FDA, ISO and GMP Requirements

Because it is built directly within NetSuite, these controls are embedded into your daily operations - not managed in separate systems or spreadsheets.

NetSuite provides a cloud-based ERP platform that enables life sciences organizations to manage financials, manufacturing, inventory, and supply chain operations within a single system. For regulated companies, NetSuite offers foundational capabilities that support compliance with standards such as 21 CFR Part 11, GMP, and ISO quality requirements, including audit trails, role-based access controls, and electronic records management.

However, implementing NetSuite in a life sciences environment requires more than standard configuration. ERP systems must be designed to align with validation processes, quality management requirements, and regulatory expectations from the outset.