All About Electronic Batch Records

An electronic batch record (EBR) software or electronic batch manufacturing record (EBMR) module of ProcessXE is a web-based solution that automates the manufacturing industries processes from raw material through manufacturing to packaging and is essentially electronic capture of data in various operations of the manufacturing industry.

Electronic batch record is used in conjunction with the many regulatory bodies. It helps all regulatory bodies to ensure the product is manufactured correctly with all required data and through proper recipe methods with compliance to ALCOA. Also ensures transparency in the whole manufacturing cycle with compliance and easy integration with other systems like TMS, LMS, SAP.

MPCR Management

EBR module is a total solution to alters manual paper-based processes of manufacturing into the electronic system with standard approval cycle review, verify, approve to ensure right & complete data recorded in the system. Which ensuring compliance with regulations such as 21 CFR part 11, Eu Annex 11, GAMP, GMP, etc. for a better experience for our clients on shop floor.

According to the GMP (Good Manufacturing Practice), manufacturers must maintain proper documentation and records throughout their production process. Proper documentation helps to understand the complete manufacturing processes which are necessary for future reference. Regulatory inspectors spend their maximum time in examining the companys various documentation and records. Effective documentation reflects the quality of company production.

EBR software provides a complete facility to create, organize & maintain master production control records (MPCR) which contain work instructions, process steps/recipe, in-process data capture fields, list of SOPs/production checklist to be used, list for raw materials.

This smart manufacturing software solution helps to capture the right data at the right time by the right person in batch process control record (BPCR) & generate significant reports and statistics to evaluate and monitor the manufacturing process and its outcome.