Reducing the Compliance Burden for NetSuite Customers
NetSuite provides superior manufacturing resource planning, leaner production processes, and improved supply chain management, benefiting organizations in the life sciences industry such as pharma and biotech. The healthcare and life sciences landscape is undergoing massive changes, leading to increased pressure to control costs and adapt to evolving regulatory and competitive conditions. To remain competitive, organizations must be able to respond quickly to market demands and changing regulations. With over 33,000 customers, NetSuite’s cloud-based business management suite helps healthcare and life sciences organizations increase visibility, reduce complexity, and remain agile in the face of dynamic changes.
This recorded session walks through the GxP-regulated use cases that matter most to life sciences NetSuite customers and shows how USDM helps close the gap between an enterprise ERP and the expectations of regulators. The challenge is well understood: a powerful business management suite still has to operate inside a validated, controlled environment where 21 CFR Part 11 compliance applies to electronic records and electronic signatures.
What You’ll Learn
- How NetSuite supports regulated use cases across item and material management, material status controls, and product revisions and change controls.
- What 21 CFR Part 11 compliance requires for electronic records, audit trails, and electronic signatures inside NetSuite.
- Where e-signatures apply across product and material management, manufacturing controls, receiving inspections and approvals, manufacturing operations, quality inspections, and UDI for medical devices.
- How USDM helps reduce the compliance burden for NetSuite customers in pharma, biotech, and medical device organizations.
- Current trends in emerging life sciences technology and compliance.
Regulated Use Cases for NetSuite Customers
A discussion on trends in emerging life sciences technology and compliance, covering:
- Item & Material Management
- Material Status Controls
- Product Revisions, Change Controls
- CFR Part 11 Compliance
- E-Records & Audit Trails
- E-Signatures for: Product & Material Management, Manufacturing Controls, Receiving Inspections & Approvals, Manufacturing Operations, Quality Inspections, UDI for Medical Devices
Building these controls correctly depends on disciplined validation and reliable data integrity in life sciences, so that e-records and audit trails hold up under inspection.
USDM’s point of view: An ERP like NetSuite can be a strong foundation for regulated life sciences operations, but compliance is not automatic. The value comes from configuring and validating the platform so that electronic records, audit trails, and electronic signatures meet regulatory expectations across the manufacturing and quality lifecycle. A risk-based approach grounded in computer software assurance (CSA) lets teams focus validation effort where patient safety and product quality risk is highest — and keep that validated state intact as the platform evolves.
Presenters
- Alex Sanchez – Product Portfolio Manager, USDM
- Ken Staresinic – VP 14.OS SmartFactory, Providence Consulting
- Peter Bouyounan – Principal Industry Solution Advisor, NetSuite
Frequently Asked Questions
What does NetSuite offer life sciences organizations?
NetSuite is a cloud-based business management suite that provides manufacturing resource planning, leaner production processes, and improved supply chain management. For pharma, biotech, and medical device organizations, it helps increase visibility, reduce complexity, and stay agile as regulatory and competitive conditions change.
Can NetSuite be used for GxP-regulated processes?
Yes. This session covers regulated use cases including item and material management, material status controls, product revisions and change controls, e-records and audit trails, and e-signatures across manufacturing and quality operations. Realizing these use cases in a compliant way depends on proper configuration and validation of the platform.
How does 21 CFR Part 11 apply to NetSuite?
21 CFR Part 11 governs electronic records and electronic signatures in regulated environments. For NetSuite customers, that means electronic records must be trustworthy, audit trails must capture changes, and electronic signatures must be applied appropriately across product and material management, manufacturing controls, inspections and approvals, quality inspections, and UDI for medical devices. Learn more about 21 CFR Part 11 compliance.
Where do electronic signatures apply in a regulated NetSuite environment?
The session highlights e-signatures for product and material management, manufacturing controls, receiving inspections and approvals, manufacturing operations, quality inspections, and Unique Device Identification (UDI) for medical devices.
How does USDM help NetSuite customers with compliance?
USDM helps reduce the compliance burden for NetSuite customers by addressing regulated use cases and applying a risk-based approach to validation. To discuss your NetSuite environment with USDM, contact us.
Watch the On-Demand Webinar
See how USDM helps NetSuite customers cover GxP-regulated use cases and reduce the compliance burden. To keep your validated systems compliant over time as they change, explore USDM Cloud Assurance, or contact us to talk through your specific use cases.
Please email usdm@usdm.com with any questions.