Non-compliance with GMP regulations, particularly in critical factors such as data integrity and employee identification in manufacturing tasks, can lead to regulatory agencies issuing warning letters and even suspending manufacturing operations. How do you effectively address and prevent these consequences to ensure compliance?

The FDA and EMA share the goal of ensuring compliance with GMP and other applicable regulations in pharmaceutical manufacturing. These entities carry out exhaustive inspections of companies to verify their compliance with established standards. Is your company ready to face the rigorous inspection processes?

RFID cards provide some advantages when used for access control and as an electronic signature for employees in pharmaceutical production processes. However, they present a series of inconveniences that make the regulations themselves not accept them as the exclusive method of identification.

In many pharmaceutical companies, employees record their manufacturing actions on paper with handwritten signatures, which creates risks and inefficiencies. It is possible to digitize these processes in a simple way and add the security of the biometric electronic signature.