Template on Card: How Pharma Manufacturers meet GMP and GDPR requirements

In the pharmaceutical industry, every action performed on a regulated system must be unambiguously traceable to a specific individual, that’s a non-negotiable GMP requirement. Biometrics is the most reliable method for achieving that. But GDPR has raised serious questions about the viability of centralized systems that store biometric templates on a server. Template on Card (ToC) technology offers a direct answer to this challenge where the worker’s biometric template is stored on their own smart card, ensuring that identity verification stays local and secure.

Why traditional Identification methods fall short in GMP environments

In pharmaceutical manufacturing, unauthorized access doesn’t just create compliance headaches, it has direct consequences for patient safety. That’s why European GMP  (Good Manufacturing Practices) regulations require that the IT systems used in manufacturing include authentication mechanisms that ensure only authorized personnel can access data and carry out operations.

Despite this, many pharmaceutical facilities still rely on PIN codes, passwords, or RFID cards for identification, even though none of these meet the security standards the regulations demand. For a closer look at where these methods fall short, see our articles on Problems using login and password as electronic signature in pharmaceutical manufacturing and Challenges of using RFID cards in the pharmaceutical industry.

The FDA (Food and Drug Administration) similarly requires that electronic signatures be unique to each individual and cannot be reused or reassigned. The WHO, in its Good Data and Record Management Practices guidance, is equally explicit that the authentication systems must ensure that only the authorized individual can electronically sign or access regulated data.
Biometric signatures emerge as the natural solution to these regulatory demands. Because they’re based on non-transferable biometric data, they guarantee that every system access is genuinely authorized.

GDPR Biometric data in Pharmaceutical settings: The Regulatory Landscape

Recent interpretations of Article 9 of the GDPR, which classifies biometric data used to uniquely identify an individual as a special category of data, have sparked an active debate across the pharmaceutical sector about how to handle this type of information with the rigour it demands. While recognized legal bases do exist in pharmaceutical environments for using biometrics as an authentication mechanism (given that it responds to an explicit regulatory obligation for traceability), many organizations are proceeding carefully when it comes to systems that involve centralized storage of biometric templates.

This caution is entirely reasonable. Custodying special category data on corporate servers brings real responsibilities. The compliance teams must ensure access is properly governed and that sufficient technical and organizational safeguards are in place. ToC is positioned as a particularly well-suited response to exactly this concern. By eliminating the need for a centralized biometric template repository, it significantly reduces the risk surface and simplifies regulatory compliance, without sacrificing the strength of biometric authentication.

Template on Card: Balancing Security, Privacy, and Operational Performance

The ToC architecture directly resolves the tension between GMP traceability requirements and the constraints GDPR places on centralized biometric systems.

Rather than storing an operator’s biometric template on a corporate server, the template is encrypted and written directly onto the worker’s personal smart card during the enrollment process. Comparison takes place locally, on the card’s chip or at the reader, meaning the biometric data never leaves the employee’s card. When an operator presents their card at an access reader or signs an electronic record, a 1:1 biometric comparison is performed locally between the biometric captured in that moment and the template stored on the card.

This architecture has concrete implications across several compliance and operational dimensions:

• Privacy by design, aligned with GDPR. With no centralized server and no biometric template database, the risk of biometric data exposure is drastically reduced, making GDPR compliance substantially easier to achieve and demonstrate.
• GMP environment compatibility. ToC is compatible with cleanroom hygiene protocols. It can be used with gloves and requires no direct physical contact. Authentication completes in seconds, without interrupting production workflows, improving operational efficiency compared to traditional methods. For more on this, see our article on Biometric electronic signature in pharmaceutical manufacturing processes.
• Robust access control. The electronic signature is tied to two factors: something the worker has (the card) and something the worker is (their biometric data). This means no third party can authenticate as the operator, even if the card is stolen or lost.
• A complete audit trail. As we explore in our article on Employees’ identification in the pharmaceutical industry according ALCOA+, unambiguous attribution of every action is one of the core pillars of data integrity in GMP environments. With ToC, every action is recorded and inseparably linked to the biometric identity of the operator who performed it.

In short, Template on Card reconciles security, privacy, and operational continuity, delivering strong biometric authentication with biometric data that never leaves the user’s card. It’s one of the most compelling answers available to the challenge of managing GDPR biometric data in pharmaceutical manufacturing without weakening the authentication layer that GMP compliance demands.

Find out how Verázial ID bridges the gap between GMP regulations and GDPR, while giving workers full control over their own biometric data. 

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