MMR and BPR Documents

Designed a compliant batch record system (FDA CFR 21) to replace Excel-based processes, which often lack control and scalability. This solution systematizes batch record creation, ensuring regulatory compliance, synchronization with the ERP system, and streamlined updates as regulations evolve. It i


NetSuite Customization: Automating MMR (Master Manufacturing Record) and BPR (Batch Production Record) Creation

The creation and management of Master Manufacturing Records (MMRs) and Batch Production Records (BPRs) is a vital part of manufacturing operations, particularly in FDA-regulated industries. Popular alternatives often rely on complex Excel implementations with separate files for each product. While functional, this approach introduces inefficiencies and risks, such as mismatched data between the ERP system and Excel documents, and costly, time-intensive updates.

Use Case: Streamlined MMR and BPR Creation

In this project, I designed a NetSuite customization to generate MMRs and BPRs directly within the ERP system. By leveraging NetSuite’s ability to customize code and create custom record sets, this solution eliminates the need for external tools like Excel. The integration ensures that all data—such as BOMs, batch sizes, and production requirements—remains consistent and synchronized within a single system.

Key Features and Benefits

  • Data Consistency: Ensures BOMs and production details are always up-to-date, reducing the risk of discrepancies between ERP and external documents.
  • Approval and Control: Integrates approval workflows, enforces master batch size limitations, and controls who can print records and when.
  • Compliance and Tracking: Logs when documents are generated, tracks changes to data, and records who performed each action, aiding regulatory compliance.
  • Scalability: Simplifies large-scale updates by eliminating reliance on multiple disconnected files, saving time and reducing errors.
  • Adaptability: Handles exceptions and unique requirements common in contract manufacturing, particularly in FDA-regulated environments where flexibility is essential.
  • NetSuite Advantages: Takes full advantage of NetSuite’s flexible customization capabilities, allowing tailored solutions that meet specific business needs.

Many ERP systems provide rigid, report-builder-based solutions for MMR and BPR creation, but they often struggle with the dynamic requirements of contract manufacturing. NetSuite’s customization-friendly platform enables a solution that adapts quickly to changes in regulations and customer needs, ensuring businesses stay compliant and efficient.

This project highlights how NetSuite’s flexibility can transform manufacturing processes, providing a robust, centralized system for managing critical production records. If you’re looking to streamline your manufacturing operations or enhance compliance, I can help build a solution tailored to your requirements.