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.

In many pharmaceutical companies, employees still record manufacturing control data on paper and authenticate it with their handwritten signature. This can lead to inefficiencies and errors that jeopardize data integrity.

The use of biometrics in electronic signatures solves all the current problems with passwords in GMP regulated pharmaceutical manufacturing environments. But what technologies should we use? How should they be applied?

The use of the biometric electronic signature not only ensures data integrity and compliance with pharmaceutical regulations, but also solves the problems of inconvenience and loss of time and efficiency of employees.

Password-based electronic signatures are widely used in manufacturing software (MES, ERP) in the pharmaceutical industry, putting at risk data integrity and regulatory compliance. The solution is the biometric electronic signature.

The ALCOA+ requirements defined by the FDA establish, among others, the characteristics for correct identification of employees in regulated pharmaceutical processes. The use of biometrics solves the current difficulties in meeting them.