21 CFR Part 11 requires pharmaceutical manufacturers to provide greater production transparency through audit trail and access control functions. It also puts forth the criterion that electronic records and signatures are equivalent to paper records and handwritten documents in the manufacturing processes. Therefore, companies are compelled to develop sophisticated means of electronic validation and batch recording.

Polmon’s Electronic Batch Process Recording (EBPR) is a perfect solution for the pharmaceutical industry. EBPR would provide an efficient way for automatic capturing of data, exchange of batch information, batch production management, and report generation, to increase productivity and accuracy of operators. EBPR would also provide a central storage of data to maintain data security and integrity.