NetSuite Modules to Validate in FDA-Regulated Industries

Companies in FDA-regulated industries are required to comply with stringent regulations that demonstrate your product quality and patient safety are maintained. Among these requirements is validating your Enterprise Resource Planning (ERP) system. NetSuite, in particular, features various modules that require companies to thoroughly validate them. Here, we explore the key NetSuite modules to validate and the importance of doing so.

Quality Management

Reasons to Validate: The quality management module assesses whether products meet the required quality standards and that any deviations are properly documented and addressed. Validating this module helps maintain data integrity and traceability, which are important in FDA audits.

Key Areas to Test:

• Quality Inspections
• Non-Conformance Management
• Corrective and Preventive Actions (CAPA)
• Document Control

Applicable FDA Regulations/Guidance:

• 21 CFR Part 820 (Quality System Regulation)
• 21 CFR Part 11 (Electronic Records; Electronic Signatures)

Manufacturing

Reasons to Validate: The manufacturing module manages production processes, as manufactured products must meet specific standards. Performing validation on this module ensures that manufacturing processes are controlled and documented in compliance with Good Manufacturing Practices (GMP).

Key Areas to Test:

• Production Planning
• Work Order Management
• Batch and Lot Tracking
• Equipment Calibration and Maintenance

Applicable FDA Regulations/Guidance:

• 21 CFR Part 820 (Quality System Regulation)
• 21 CFR Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals)

Inventory Management

Reasons to Validate: Proper inventory management tracks raw materials, work-in-progress and finished goods. You can measure the success of this through validation, as it confirms the accuracy of inventory records and that the system supports traceability from raw materials to finished products.

Key Areas to Test:

• Inventory Tracking
• Lot and Serial Number Management
• Expiry Date Management
• Warehouse Management

Applicable FDA Regulations/Guidance:

• 21 CFR Part 820 (Quality System Regulation)
• 21 CFR Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals)

Supply Chain Management

Reasons to Validate: This module oversees the procurement and distribution of materials and products. Validating it makes sure that supply chain processes are efficient and compliant with FDA regulations, reducing the risk of supply chain disruptions and promoting product quality.

Key Areas to Test:

• Supplier Qualification and Management
• Purchase Order Processing
• Receiving and Inspection
• Distribution and Logistics

Applicable FDA Regulations/Guidance:

• 21 CFR Part 820 (Quality System Regulation)
• 21 CFR Part 11 (Electronic Records; Electronic Signatures)

Regulatory Compliance

Reasons to Validate: The regulatory compliance module helps manage compliance with various regulatory requirements, including FDA regulations. By validating this module, you can evaluate whether your system is generating the necessary reports and documentation required for FDA audits and inspections.

Key Areas to Test:

• Compliance Reporting
• Audit Trail Management
• Electronic Signatures (21 CFR Part 11)
• Regulatory Submissions

Applicable FDA Regulations/Guidance:

• 21 CFR Part 11 (Electronic Records; Electronic Signatures)
• 21 CFR Part 820 (Quality System Regulation)

Customer Relationship Management (CRM)

Reasons to Validate: Companies use CRM systems to manage customer interactions—addressing and documenting feedback or complaints. Validation makes sure this system supports effective communication and traceability.

Key Areas to Test:

• Customer Complaints Management
• Customer Data Management
• Sales and Service Processes
• Marketing Campaigns

Applicable FDA Regulations/Guidance:

• 21 CFR Part 820 (Quality System Regulation)
• 21 CFR Part 11 (Electronic Records; Electronic Signatures)

Key Takeaways

Validating these modules supports compliance with FDA regulations so that your ERP system performs in a way that keeps your business processes operating effectively. Each module contributes to maintaining product quality and patient safety.

By focusing on these areas, your NetSuite implementation can remain compliant and capable of supporting your business in FDA-regulated industries. Learn more about validating your ERP system by contacting the team at Sikich.

About Our Authors

Patrick Walsh is a solution architect in Sikich’s IT quality and compliance advisory practice. He has over 20 years of quality and compliance experience in the pharma industry. In his role, Patrick optimizes computerized systems validation and compliance for life science organizations.

Sudha Dudhipala is a validation manager and business systems analyst in computer systems quality and compliance, who manages validation deliverables for IT applications.