// ROBOTICS AND SMART FACTORIES TERM
Batch Record
A batch record is a detailed document that records all steps, materials, and equipment used during the production of a specific batch of a product. It's like a recipe and logbook combined.
TECHNICAL DEFINITION
A batch record, or Device History Record (DHR) in medical devices, is a comprehensive document detailing the complete manufacturing history of a specific batch of product, including raw material traceability, in-process controls, equipment used, personnel, and deviations, ensuring regulatory compliance and product accountability.
BACKGROUND
Manufacturing is the creation or production of goods with the help of equipment, labor, machines, tools, and chemical or biological processing or formulation. It is the essence of the secondary sector of the economy. The term may refer to a range of human activity, from handicraft to high-tech, but it is most commonly applied to industrial design, in which raw materials from the primary sector are transformed into finished goods on a large scale. Such goods may be sold to other manufacturers for the production of other more complex products, or distributed via the tertiary sector to end users and consumers.
READ MORE ON WIKIPEDIASYNONYMS & ALIASES
- Production Record
- Lot Record
- Manufacturing Record
- Device History Record (DHR)
USAGE NOTE
Batch records are critical for traceability and investigation in case of product quality issues or recalls.
DEVELOPERS
Organizations developing technology related to Batch Record.
Develops the Werum PAS-X MES, a leading Manufacturing Execution System for the pharmaceutical and biotech industries. Its core function is the creation and management of Electronic Batch Records (EBR) to ensure GMP compliance and enable paperless manufacturing.
Offers Opcenter Execution Pharma, an MES solution designed to completely digitalize the manufacturing processes of the life sciences industry. It provides full Electronic Batch Record (EBR) management, guiding operators and capturing all relevant data for compliance and process analysis.
Provides the Syncade Manufacturing Execution System, which enables paperless manufacturing and electronic batch records for the life sciences and specialty chemical industries. It focuses on integrating production, quality, and logistics data for improved operational excellence and regulatory compliance.
Develops PharmaSuite MES, part of its FactoryTalk software portfolio. The system is designed for regulated industries to manage recipes, orchestrate production, and generate comprehensive electronic batch records, ensuring data integrity and simplifying the batch release process.
Provides an integrated Quality Management System (QMS) that includes an Electronic Batch Records (EBR) software solution. Their technology focuses on streamlining the entire production lifecycle, from recipe authoring to final batch review and release by exception, ensuring data integrity and compliance.
Offers a no-code frontline operations platform that enables manufacturers to build their own flexible applications for managing production. Companies use Tulip to create custom electronic batch records, interactive work instructions, and quality checks, connecting human workers with machines and systems.
Develops a comprehensive Manufacturing Execution System (MES) that digitizes work orders, enforces standard operating procedures, and automatically creates detailed electronic batch records. The system enhances traceability and quality control for process and hybrid manufacturing.
Through its DELMIA brand, Dassault Systèmes offers MES solutions like DELMIA Apriso. It provides a unified platform for managing global manufacturing operations, including the creation of detailed 'as-built' records that function as electronic batch records for complex industries.