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One Less Risk

Why ISO 27001 certification matters for your FDA audits

Jen Chang
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Blue Mountain

Wed, 01/14/2026 - 12:02
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Increasingly, inspectors for the U.S. Food and Drug Administration (FDA) will evaluate your CMMS provider’s security controls—not just your internal procedures. In a cloud-hosted GxP environment, data doesn’t stop at your firewall; your vendor’s security posture becomes part of your compliance story.

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That’s why we’re pursuing ISO 27001 certification—the global standard for information security management systems. For life sciences organizations already managing 21 CFR Part 11 compliance, ALCOA+ data integrity requirements, and endless vendor qualification questionnaires, this certification means working with a software provider whose security controls have been independently audited against international standards.

Translation: One less vendor risk to document. One less security assessment to perform. One more piece of evidence when auditors ask how you validate your suppliers.

 …

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