Electronic Batch Reporting (EBR)

Electronic Batch Reporting (EBR)

Agidens has extensive experience in the field of electronic batch reporting, so that we are able to complete your EBT project quickly and successfully.

The sooner you are able to bring a medicine batch onto the market, the better it is for your organisation. Therefore Agidens helps you to act fast and to implement 21 CFR Part 11 smoothly.

Our approach to electronic batch reporting

Our EBR approach guarantees the correct solution for your electronic batch records and is fully qualified. Our approach goes through the following phases:
  • Quick scan
  • Suggestion of a solution
  • Implementation
  • Commissioning
  • Qualification

Benefits of electronic batch reporting

Electronic batch records accompany your operator through every step in the process with electronic work instructions and so ensure a more rapid and streamline production process. Other benefits of electronic batch reporting:
  • Simplifies the complexity of the production process
  • Markedly reduces possible errors, deviations and omissions
  • Creates a central database with all executed records and relevant data
  • Ensures batch records that can no longer be changed
  • Ensures full traceability of all production data gathered