A system that prioritizes GMP compliance is essential for ensuring consistent production according to quality standards and legal regulations. Not only are BDO Digital’s custom NetSuite solutions GMP-compliant — they also help your organization simplify meeting compliance requirements.

In-House Compliance without the Big Expense

Standard NetSuite software can accommodate generic manufacturing solutions; however, it’s not ideal for pharmaceutical and biotech spaces. By enhancing basic NetSuite software with our industry-specific solutions, BDO Digital has created a scalable platform that has all the tools necessary for a GMP-compliant process.

Key Features

Vendor onboarding and management

Maintain stronger relationships with suppliers by providing a cloud-based vendor portal for collaboration, communication and connection. Vendor scorecards track and analyze every transaction so you can monitor performance and change vendors if needed.

Inventory management

NetSuite's system limits inventory movement by status, enabling automated lot inspection and reporting via custom dashboards and alerts.

Batch-release and sample management 

A centralized repository lets you view and manage all sample and batch data from one location, so you can more efficiently coordinate sourcing, storage, shipment and product release.

GMP system validation 

All the documentation needed for validation is already written, and upon delivery of your system, our team will help your organization complete and record the system testing.

Purchasing process 

From APIs to secondary packaging, new equipment and miscellaneous lab equipment, all purchases are automatically logged by their class, associated trial and candidate. Easily run reports and maintain complete control over every department’s purchasing.

Barcoding and WMS

BDO Digital provides everything an organization might need in its facility, plus an integrated WMS system, from labels to handheld devices and printers.

Final product release/material lot inspection

Every lot of raw materials received or product produced for GMP manufacturing requires a review. BDO Digital’s system captures all relevant data and documentation and adheres to 21 CFR Part 11/Annex 11 requirements in the lot release process.

Security configuration

The FDA's 21 CFR Part 11 requires companies to validate their electronic systems and documents for quality and compliance. Automated solutions are most effective for this, and BDO Digital provides automatic 21 CFR Part 11 compliance, personnel training, and auto-generated audit trails for any captured document and data.

Dashboard, reports and alerts

All the important information you need is at your fingertips, and everything else is within arm’s reach. Built-in, optimized system dashboards for each role give a 10,000-foot view, with the ability to drill down to any level of detail required for operation, automatically generate reports and receive alerts.