Manufacturing
Manufactuers that comply with FDA regulations and cGMP requirements must keep master batch records, which are also referred to as:
• Master production records.
• Master manufacturing records.
• Batch production records.
Understand common terms associated with batch records. Know how they fit together.
Device Master Record: A summary of all instructions and specifications from production of a product from start to finish.
Device History Record: All records from the manufacture of a particular finished product.
Lot History Record: Documentation related to a certain product lot. The lot history record authorizes and controls the production of a single lot of components or finished devices.
Faster review times are just one benefit of electronic batch records.
Download the Free Product Data SheetReviewed on Capterra
"Overall MasterControl Manufacturing Excellence has been great for our business.
I like that it is a great way to control documents and their revision history. Great collaboration tools for new documents."
Reviewed on G2
"MasterControl's manufacturing excellence tool provides a great alternative to paper production records. The ability to enforce good record keeping in a flexible way is a great way to reduce quality review time.
Elimination of quality reviews is the biggest benefit but also reduction of paperwork inside our cleanroom is a big benefit."