Certified Email in the Pharmaceutical Sector: Ensuring Integrity, Quality, and Regulatory Compliance

The pharmaceutical and healthcare sector is, by definition, one of the most regulated in the world. Companies in the healthcare field —laboratories, distributors, medical device manufacturers, CROs, or diagnostic companies— must guarantee the integrity, traceability, and preservation of their communications in highly sensitive areas such as pharmacovigilance, clinical trials, regulatory compliance, or shortage and alert management.

Despite this high regulatory requirement, many organizations still face a significant risk: the inability to reliably prove certain essential communications, which can lead not only to financial penalties, but also to reputational losses and legal liabilities. This is where certified email becomes a strategic compliance tool.

The Imperative Need for Certification in the Pharmaceutical Sector

Healthcare legislation requires companies to be able to demonstrate that they have made critical communications on time and in the proper manner, as well as to prove the integrity of the content sent. The lack of reliable evidence is considered a serious violation in areas such as:

• Pharmacovigilance, according to R.D. 577/2013.
• Internal and external compliance, under R.D. Legislative 1/2015, Fenin Code and Farmaindustria Code.
• Research and clinical trials, regulated by R.D. 1090/2015.
• Crisis management, alerts, and product recalls, under R.D. 824/2010.

Traditionally, many communications were made via ordinary email, a channel that presents serious deficiencies:

• It does not allow reliably proving delivery or content.
• The message can be altered or denied by either party.
• It does not guarantee sufficient probative traceability for inspections, audits, or litigation.

The classic alternative —burofax or certified postal notifications— is costly, slow, poorly scalable, and difficult to integrate into digital workflows.

eEvidence: A Certified Electronic Delivery Solution Aligned with eIDAS

eEvidence offers a certified electronic delivery solution that proves sending, the complete content of the message, and its delivery to the recipient, without requiring any action on their part. The service is regulated by Regulation (EU) 910/2014 (eIDAS), which guarantees its full legal validity throughout the European Union.

The essential benefits for the pharma sector are:

1. Enhanced legal security: Proves compliance with notification obligations, with validity before inspections, audits, and administrative or judicial proceedings.
2. Immutable custody: Certificates include a complete copy of the message, cryptographic fingerprints, and transmission record, preserved with immutability.
3. Operational efficiency: A fast, economical method, integrable with digital systems and suitable for mass or recurring communications.
4. Total scalability: Ideal for departments that manage hundreds or thousands of sensitive communications per year.

Use Case: Roche Diagnostics and Quality and Safety Communications

An illustrative example of real application is the project developed with Roche Diagnostics. The company needed to send quality and safety notices to its customers, guaranteeing effective delivery and traceability.

Communications such as medical device alerts, quality incidents, or technical instructions require:

• Verifiable evidence of delivery.
• Complete audit record.
• Seamless integration with internal systems.

To meet these requirements, Roche implemented eEvidence’s certified email workflow in its centers in Europe and America. The integration allows:

1. Composing and sending emails from the user’s usual environment.
2. Routing messages through eEvidence’s certified gateway.
3. Automatically registering and certifying sending, content, and delivery.
4. Retrieving evidence effortlessly at any time, even years later.

Additionally, an internal interface was developed that allows users to manage sends, while eEvidence’s API facilitates querying statuses and downloading evidence certificates.

A Solution That Provides Regulatory Rigor and Efficiency

The application of certified email in the pharmaceutical sector not only guarantees compliance with legal obligations: it also transforms document management into a more secure, efficient, and auditable process.

In areas such as pharmacovigilance, crisis management, or clinical trials, having unlimited and immutable custody of all communications is a critical advantage. Certification converts email —a channel that is inherently vulnerable— into a solid and verifiable tool to meet the quality and safety standards required by healthcare regulations.

Analogy to Clarify Integration

Certified email can be visualized as an automated digital notary connected to the company’s usual communication system. The message is drafted as always, but before it reaches its recipient, an invisible notary generates evidence of its content and delivery, electronically seals it, and preserves it for the future.

If years later an audit or court requests proof that the notification was sent and made available, the company simply presents that certified document: valid, complete, and incontestable.