A batch record documents the history of a manufactured product. It includes processing instructions to ensure its safety, quality, and conformance to GMPs. Batch records also contain specific information about product tests including analytical methods used and test results.
The FDA requires different Master Production Records for each formulation and batch size, which can be complicated to manage.Using electronic batch records simplifies this process and reduces human error.
WITH INTELLECT'S ELECTRONIC BATCH RECORDS SOFTWARE, YOU CAN:
Document Batch Production Processes with MPRs.
Show Compliance with Good Manufacturing Practices.
Create a Bill of Materials (BoM)
List Item
Set Up In-Process Tests
ID Batches and Batch Yields
Create Batch Review Processes
Complete Quality Control Checks and Sign offs.
Email Notifications for Task Assignment & Overdue Tasks.