Pharmacovigilance and data security: why we chose ISO 27001 certification

Data protection in pharmacovigilance demands high standards and ongoing commitment. In this article, we explain why we decided to certify our systems with ISO 27001 and what it means to work with a partner that adopts a structured approach to information security.

Anyone working in pharmacovigilance knows that data is more than just information—it’s a responsibility. Protecting it is not just a technical duty; it’s a fundamental requirement for operating ethically, compliantly, and sustainably.

With this shared awareness, Max Application, provider of SafetyDrugs, the database used for pharmacovigilance management, chose to go a step further: to become ISO 27001 certified. This decision was made to better meet our clients’ needs for security and reliability, and it was accompanied by a series of organizational and operational improvements.

ISO 27001 is the world’s most recognized standard for information security management. Published by the International Organization for Standardization (ISO), it outlines the requirements for establishing, implementing, maintaining, and continuously improving an Information Security Management System (ISMS).

This system includes policies, procedures, resources, and tools to protect information from unauthorized access, loss, theft, or compromise. It applies not only to technology, but also to people, governance, and company culture.

Organizations that achieve ISO 27001 certification demonstrate that they have systematically assessed their information risks and implemented appropriate measures to manage them. The standard also requires senior management involvement, staff training, and continuous monitoring of all critical processes.

Today, information security is increasingly vital for those working in regulatory and pharmaceutical fields. ISO 27001 certification offers internationally recognized assurance that an organization has adopted a structured and measurable approach to data protection.

Max Application has always operated in highly secure environments, thanks in part to the Oracle data centers where pharmacovigilance data is hosted. However, ISO 27001 certification adds another layer. It’s not just about where the data resides—it’s about how it is managed daily. The responsibility for data security is a constant collaboration between us and our technology partners.

This certification, issued by the independent body Certiquality, confirms that Max Application has implemented an Information Security Management System that can:

• ensure the confidentiality of sensitive and strategic data;
• guarantee business continuity, even in critical situations;
• maintain data traceability and integrity to comply with regulatory obligations;
• continuously and systematically adapt to technological and regulatory changes.

In pharmacovigilance, where every piece of information can make a difference, this approach isn’t just useful, it’s essential.

For those involved in pharmacovigilance, it’s essential to ensure that every report, every piece of data, and every submission is complete, verifiable, and ready for regulatory authorities—and always available for audits or inspections.

Working with an ISO 27001 certified partner means relying on data management that is structured, transparent, and aligned with international standards:

• your data is hosted in controlled environments that follow best security practices;
• proven procedures are in place to prevent and promptly address any critical issues;
• you can count on a partner who has integrated security into its daily operations, with the goal of protecting, informing, and supporting pharmacovigilance professionals.

ISO 27001 is not a final goal. It is a commitment: to constantly improve processes, stay updated on new security technologies, anticipate threats, and align with evolving regulatory requirements. We will continue to invest in what truly matters: the security of your data and the peace of mind in your daily work.