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.

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.

The vendor question asked in every audit

We’ve all lived through this moment: An auditor pulls up your supplier qualification documentation and asks, “How do you verify that your CMMS provider maintains appropriate security controls for GxP data?”

You hand over security questionnaires, attestation letters, and internal assessments. Maybe you reference SOC 2 reports. But there’s often a gap—a lack of systematic, independently verified evidence that your vendor manages information security with the same rigor you apply to manufacturing.

ISO 27001 closes that gap. The ISO/IEC 27001: 2022 standard, “Information security, cybersecurity, and privacy protection—Information security management systems—Requirements,” provides a systematic framework for managing information security risks. First published in 2005, and updated in 2022, ISO 27001 is now the globally recognized benchmark for organizations handling sensitive data.

For pharmaceutical, biotech, and medical device manufacturers, this matters because your vendor’s security failures become your compliance problems. A data breach at your CMMS provider doesn’t just expose calibration records; it triggers deviation reports, regulatory notifications, and potentially compromised GMP operations.

Why ISO 27001 resonates in life sciences

The life sciences industry is no stranger to ISO standards. You’re already implementing ISO 9001 for quality management and ISO 13485 for medical device QMS (which will be formally incorporated into 21 CFR 820 as the Quality Management System Regulation in February 2026). ISO publishes standards covering everything from sterilization to biological evaluation to risk management.

ISO 27001 extends this systematic thinking to information security. Although it’s not a direct GxP regulation, it reinforces the same principles you already follow: documented procedures, risk-based controls, continuous improvement, and independent verification.

Here’s where it connects to your daily reality.

You’re moving from on-premises systems to validated SaaS platforms. How do you verify that your cloud provider maintains a validated state through software updates, infrastructure changes, and security patches? ISO 27001 certification provides documented evidence of change control, configuration management, and release management processes—the same controls you need for computer system validation.

IT directors: Validated cloud deployments. When remote regulatory assessments pull calibration records, deviation logs, or change histories, you must have confidence that those records haven’t been compromised. ISO 27001’s requirements for access controls, audit logging, and data backup align directly with 21 CFR Part 11 expectations. Independent certification gives you defensible documentation when auditors ask about vendor controls.

Quality directors: Audit readiness. What happens if your CMMS goes down during a critical production run or calibration window? ISO 27001 requires formal business continuity and disaster recovery planning with defined RTOs, backup procedures, and incident response protocols. This isn’t optional capability. It’s audited requirement.

Maintenance and facilities: Business continuity. Your calibration data are GxP evidence. Any unauthorized modification—whether malicious or accidental—creates data integrity violations. ISO 27001’s cryptographic controls, access management, and change detection mechanisms protect calibration records throughout their life cycle, from as-found measurements to CAPA closure.

Metrology managers: Secure calibration records. Predictive maintenance and failure analysis depend on trustworthy historical data. ISO 27001’s asset management and operations security controls ensure the maintenance data feeding your reliability models haven’t been corrupted, lost, or tampered with.

Reliability engineers: Data-driven decisions.

What ISO 27001 certification actually delivers

ISO 27001 isn’t a check box. It’s a management system spanning 93 security controls organized across four themes (organizational, people, physical, and technological).

Here’s what matters most for GxP environments.

Risk-based information security: Just as you apply ICH Q9 quality risk management principles to manufacturing, ISO 27001 applies systematic risk assessment to information assets. Blue Mountain’s regulatory asset management platform identifies threats to your GxP data, evaluates likelihood and effect, and implements proportionate controls. Annual surveillance audits verify that the platform maintains those controls.

Cryptographic controls: Data in transit (TLS 1.3, with TLS 1.2 for legacy systems) and at rest (AES-256 encryption) protect calibration results, audit trails, and electronic signatures, directly supporting Part 11 requirements for data security and integrity.

Access control and authentication: Role-based permissions, multifactor authentication, password policies, and session management prevent unauthorized access to GxP records.

Change management: Documented procedures for system changes, patches, and updates with impact assessment, testing requirements, and rollback procedures align with your own change control expectations and support an ongoing validated state.

Incident response: Formal procedures for detecting, responding to, and recovering from security incidents with defined escalation paths and notification requirements.

Supplier management: Security assessments of subprocessors and service providers extend protection across the entire data chain—critical because Blue Mountain RAM integrates with QMS, LIMS, MES, and ERP systems.

Business continuity: Documented recovery procedures, backup strategies, and continuity plans tested through regular exercises.

Audit and monitoring: Continuous logging of security events, regular security reviews, and annual surveillance audits by independent assessors—the same continuous improvement cycle you follow for GMP.

What ISO 27001 doesn’t do

ISO 27001 isn’t a substitute for GxP validation or 21 CFR Part 11 compliance. It doesn’t certify software functionality or guarantee data integrity on its own. Instead, it strengthens the underlying security and risk-management controls that your validated system depends on.

Think of it this way: ISO 27001 verifies that Blue Mountain manages information security systematically. Your site-specific validation confirms that the system works correctly in your environment. Both are necessary. Neither alone is sufficient.

The validation advantage

Here’s the practical benefit: ISO 27001 certification reduces your validation burden.

When you’re validating Blue Mountain RAM under GAMP 5 guidelines, you need evidence that its infrastructure and development practices meet GxP expectations. ISO 27001 provides:
• Independent verification of security controls through third-party audits
• Documented procedures for change control, testing, and release management
• Traceable evidence of access controls, cryptographic implementations, and backup procedures
• Continuous monitoring through annual surveillance audits—your validation stays current

Under GAMP 5, ISO 27001 certification strengthens Category 3 and 4 supplier assessments by providing independently verified evidence of procedural controls, risk management, and software life cycle practices.

This doesn’t replace your site-specific validation (e.g., configurations, integrations, workflows), but it substantially reduces the vendor qualification effort. Instead of creating custom security assessments, you’re referencing a globally recognized framework already validated by independent auditors.

Multitenant cloud environments deserve special attention. For organizations adopting validated SaaS, inspectors now routinely ask how multitenant environments segregate customer data. ISO 27001 certification provides independent verification of access segregation, logical separation controls, and infrastructure hardening—controls that are notoriously difficult for customers to verify on their own.

Ask vendors without ISO 27001 certification:
• How do you independently verify your security controls?
• What evidence can you provide of systematic risk management?
• How often are your security practices audited?
• What happens when you update infrastructure—how do you maintain a validated state?

The answers often involve lengthy questionnaires, customer audits, and trust—but not independent verification.

Why this matters now

The regulatory landscape is tightening around vendor management and data security.

FDA emphasis on data integrity: Recent warning letters cite vendors as sources of data integrity violations—incomplete audit trails, uncontrolled data access, and inadequate backup procedures.

Rise in cybersecurity incidents: Pharmaceutical manufacturing is increasingly targeted. Ransomware, data breaches, and supply chain attacks aren’t theoretical. They’re affecting regulated operations with real patient safety implications.

Validated cloud adoption: As organizations move from on-premises to cloud-native platforms, inspectors are asking harder questions about cloud security, multitenancy controls, and infrastructure validation.

Vendor audits becoming standard: Supplier audits now routinely include information security assessments. Responding to custom questionnaires from every customer is inefficient. ISO 27001 provides standardized evidence.

Harmonization across sites: Multisite organizations need consistent security controls across all locations. ISO 27001 certification covers all operations; your security posture doesn’t vary by geography.

Our path forward

We’re currently completing our ISO 27001 certification process with an accredited certification body. This involves:
• Comprehensive risk assessment across all Blue Mountain operations
• Implementation and documentation of security controls mapped to Annex A requirements
• Internal audit and management review cycles
• Independent third-party audit and certification
• Ongoing surveillance audits to maintain certification

We’ll continue to share more details about our ISO 27001 journey, including how we’ve embedded these controls into Blue Mountain RAM’s architecture, what this means for your validated deployments, and how certification supports your ongoing compliance needs.

This isn’t just about meeting a standard—it’s about building a culture of security and trust that supports your operations in an increasingly digital, regulated landscape.

Published Nov. 17, 2025, by Blue Mountain.