MasterControl Electronic Batch Records (EBR)

About this Document

Proof of proper handling for every step in the production of each batch of a drug product is essential to quality management and FDA compliance. Further, batch records executed and documented electronically must comply with 21 CFR Part 11 requirements. MasterControl Electronic Batch Records (EBR) provides the tools needed to create electronic batch record forms that are compliant and support your organization's specific needs, delivering complete data capture, data integrity checks, automated calculations, performer/witness signoff and much more.