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 Sheet
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