Drowning in documentation: There’s A better Way

Drowning in documentation: There’s A better Way

Pharmaceutical companies have been using a paper based documentation system for years now. Companies have been slowly transition to electronic systems for various items including qualification documentation and user requirements among others. One area that has been slow to hop on the electronic records train is batch records.

Electron Batch Records (EBRs) were accepted by the FDA in 1997 as a system that showed compliance with FDA regulations. Making the switch to EBRs has been slow and is an expensive and time consuming process; However provides many benefits.

This includes:

  • Accurate data entry into required fields
  • Faster execution
  • Easily traceable and searchable
  • Provides analytics reporting

With all the benefits EBRs provide, they are indispensable when it comes to maintaining records on pharmaceutical product batch processing.