ELECTRONIC BATCH RECORDING (eBR)

+95%

Right First Time

-75%

Deviations in the Batch Record

-75%

Batch Record review time

-75%

Data input times

21 CFR Part 11

Compliance

 GMP & FDA Compliance

The substitution of the paper manufacturing guide with an electronic guide or Electronic Batch Recording (eBR) represents a strategic decision that requires the direct involvement of general management due to its impact on the policies and procedures governing the company. Moreover, its effect will be very cross-functional, affecting most of the factory’s departments. 

The implementation of an Electronic Guide will enable us to manage and track manufacturing orders, as well as the materials and equipment (Electronic Logbooks) involved in them. We will have real-time inventory information, the flow of materials (MFC) involved in the manufacturing order, and their status. Through the EBR, we will manage manufacturing instructions interactively, predefining workflow processes and accurately sequencing the different steps to be executed. All of this will be done electronically with real-time exception-based review. 

 

BARCELONA

MADRID

Carretera M-603 Fuencarral a Alcobendas

Portal nº 44, Edificio 6, Piso Bajo, Puerta 23

28108, Alcobendas, Madrid