Audit Trail to ensure data integrity in the pharmaceutical manufacturing process

The biometric electronic signature within the audit trail action log ensures the integrity of records in GMP regulated environments, providing detailed and reliable tracking of recorded activities.


GxP environments and their relevance to the pharmaceutical industry

Within GxP regulated environments, it is essential to ensure data integrity and traceability of actions throughout the supply chain. The adoption of biometric technologies, such as iris or fingerprint recognition, emerges as the solution to ensure compliance.


Consequences of non-compliance with data integrity in the pharmaceutical industry

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?


FDA inspections in the pharmaceutical industry

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?


Challenges of using RFID cards in the pharmaceutical industry

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.


What are the disadvantages of using handwritten signatures in pharmaceutical process control?

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.


Challenges in the control of pharmaceutical manufacturing processes on paper

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.


Biometric electronic signature in pharmaceutical manufacturing processes

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?

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