Electronic Batch Record (EBR) Software Systems

Ensure EBR Compliance by Digitizing and Integrating Your Processes

For pharmaceutical companies, accountability is an important part of quality management and FDA compliance. Batch production records and other types of manufacturing documentation demonstrate accountability by providing the proof of proper handling for every step in producing each batch of a drug product, which is required by FDA Current Good Manufacturing Practice (CGMP) regulations. Manufacturers that manage their batch records electronically must also comply with 21 CFR Part 11 requirements.

MasterControl Electronic Batch Records™ (EBR)