From paper to platform: Electronic batch record engineering for pharmaceutical manufacturing
EBR is not a digitization project but a transformation of control strategy
By Subash Senthil Mohanvel
Every pharmaceutical batch released to market carries a documentation burden that rivals the complexity of the
manufacturing process itself. Thousands of data points – raw material certifications, equipment status, in-process
measurements, operator signatures, environmental readings, deviation records – must be reconciled, verified and
approved before a single unit reaches a patient. For decades, this burden has been carried by paper.
You must be an IISE member to have full access to this content. Please log in at the top right corner of this Web page.
IISE members visiting this site for the first time must register. As part of this process you will create a user name and password. This is a one-time process that requires your member number.
If you are not a member, join IISE now and begin enjoying benefits immediately, including full access to ISE magazine.