Good Manufacturing Practices (GMP), the industry standard specifies that the manufacturing process should be thoroughly documented. As manufacturing processes are pre-defined to specifications and quality standards, documenting each batch provides evidence that proper protocols have been diligently followed. This aids in the production of quality, uniform goods. During the manufacturing process, a written document is prepared that includes detailed information about each particular batch. Batch manufacturing records include information including:
- The step-by-step process for producing each batch
- Ingredients and components
- Verification that each step during processing is completed according to SOP
Software applications the store and manage data electronically for each batch produced in addition to the entire manufacturing process on a step-by-step basis. EBR software typically relies on another system such as a manufacturing execution system or enterprise resource planning system to systematically generate a formal master batch record or EBR. This master record stores all the materials, processes and activities which were required for the production of a given product. Electronic batch records provide the structure and means for automatically compiling batch production data into a formatted electronic document, reducing paper and manual records for more accurate record keeping. Data is recorded and stored in encrypted form, guaranteeing data privacy and security.