21 CFR Part 11 Compliance in Cloud-Based Regulatory Systems: What You Need to Know

21 CFR Part 11 Compliance in Cloud-Based Regulatory Systems: What You Need to Know

Moving regulatory operations to the cloud is no longer a question of if but when. The business advantages — faster deployment, reduced IT overhead, continuous updates — are well understood. But for Senior Directors of Regulatory Affairs and Regulatory Operations, there is a harder conversation happening in parallel: convincing your validation and quality teams that a cloud-based platform can meet 21 CFR Part 11 requirements as rigorously as an on-premise system.

This post addresses that conversation directly. We will walk through the key Part 11 requirements, explain how a modern cloud-based regulatory platform like DnXT addresses each one, and provide practical guidance for evaluating any cloud vendor’s compliance claims.

1. Electronic Signatures

The requirement: Under 21 CFR Part 11, electronic signatures must be attributable to a specific individual and include the meaning of the signature (such as approval, review, or authorship). Signatures must be linked to their respective electronic records so that signatures cannot be excised, copied, or transferred to falsify a record. Each electronic signature must include the printed name of the signer, the date and time of signing, and the meaning associated with the signature.

How cloud platforms address this: A well-designed cloud platform implements role-based electronic signatures tied to authenticated user identity. In DnXT, electronic signatures are bound to the user’s LDAP-authenticated credentials, ensuring that the signer is positively identified through the organization’s own directory service. The signature record captures the user’s identity, the action taken (approval, review, authorship), and the precise timestamp — all stored immutably alongside the document record.

What to verify: Ask whether signatures are truly bound to authenticated identity or merely self-asserted. Confirm that the signature meaning is captured as structured data, not free text. Ensure signatures cannot be applied by one user on behalf of another without explicit, auditable delegation.

2. Audit Trails

The requirement: Systems must generate secure, computer-generated, time-stamped audit trails that independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Audit trail documentation must be retained for a period at least as long as the subject electronic records and must be available for agency review and copying.

How cloud platforms address this: This is an area where cloud platforms can actually exceed the capabilities of on-premise systems, because the audit infrastructure is centralized and maintained by the vendor rather than dependent on local IT practices. DnXT maintains immutable audit logs for every action within the system: document access, annotation creation and modification, status changes, approval workflow transitions, user login and logout events, and administrative configuration changes. Each log entry captures the user, timestamp, action type, and both the previous and new values for any data modification. These logs cannot be modified or deleted by any user, including system administrators.

What to verify: Ask whether audit logs are truly immutable or merely access-restricted. Confirm that the audit trail captures old and new values for modifications, not just the fact that a change occurred. Verify that audit data is retained independently of the records it documents and that retention periods meet your organizational requirements.

3. Access Controls

The requirement: Systems must enforce controls to limit system access to authorized individuals. Access authorization and user account management must be documented. Systems must use operational checks to enforce event sequencing (for example, preventing approval before review is complete).

How cloud platforms address this: DnXT implements role-based access control with granular permissions that can be configured to match your organizational structure. Roles define what actions a user can perform — viewing, annotating, approving, publishing, administering — and are assigned through a controlled process with full audit trail. The platform integrates with enterprise directory services via LDAP, so user provisioning and deprovisioning follows your existing identity management processes. Session security enforces configurable timeouts to prevent unauthorized access from unattended workstations.

What to verify: Ask whether role definitions are granular enough to enforce separation of duties for your workflows. Confirm that the platform supports integration with your existing identity provider rather than requiring a separate user database. Verify that session management policies (timeout, concurrent session limits, lockout after failed attempts) are configurable to your organization’s security requirements.

4. System Validation

The requirement: Persons who use closed systems to create, modify, maintain, or transmit electronic records must employ procedures and controls designed to ensure the authenticity, integrity, and confidentiality of electronic records. This includes validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

How cloud platforms address this: System validation for cloud-based platforms follows GAMP 5 principles, but the responsibility model differs from on-premise systems. The vendor is responsible for validating the platform itself (Installation Qualification, Operational Qualification), while the customer is responsible for Performance Qualification specific to their use cases and configuration. DnXT provides IQ/OQ/PQ documentation packages designed for computer system validation (CSV) compliance, reducing the burden on the customer’s quality organization. Because the platform is standardized rather than heavily customized, the validation scope is more bounded and predictable than a configured ECM system.

What to verify: Ask what validation documentation the vendor provides out of the box. Confirm that the vendor’s own development and release processes follow validated lifecycle practices. Understand the revalidation impact of platform updates — a well-architected cloud platform should be able to demonstrate that routine updates do not require full revalidation by customers.

5. Data Integrity: ALCOA+ Principles

The requirement: While ALCOA+ is not explicitly stated in Part 11, it is the framework regulators use to evaluate data integrity, and it is the standard your quality team will apply. Data must be Attributable, Legible, Contemporaneous, Original, and Accurate, with the “plus” adding Complete, Consistent, Enduring, and Available.

How cloud platforms address this:

• Attributable: Every action is tied to an authenticated user. DnXT’s audit trail records who performed every operation, from document access to annotation to approval.
• Legible: Data is stored in structured formats with defined schemas. Regulatory content maintains its formatting and structure throughout the lifecycle.
• Contemporaneous: Timestamps are system-generated at the time of action, not manually entered. Server-side time synchronization ensures consistency.
• Original: The immutable audit trail preserves the original record state. Modifications create new versions; original data is never overwritten.
• Accurate: Validation checks at point of entry, rendering validation against standards like ISO 19005 for PDF/A, and automated compliance checks reduce the opportunity for inaccurate data.
• Complete and Consistent: Structured workflows enforce required fields and sequencing, preventing incomplete records.
• Enduring and Available: Cloud-hosted data with defined backup and retention policies ensures records persist and remain accessible for the required retention period.

6. Cloud-Specific Considerations

Part 11 was written before cloud computing existed, so certain cloud-specific concerns require explicit attention:

Data residency: Regulated data may need to reside in specific geographic regions. DnXT is hosted on Microsoft Azure, which provides regional data center options. Confirm that your vendor can contractually commit to data residency requirements for your organization’s regulatory obligations.

Encryption: Data must be protected both at rest and in transit. DnXT implements encryption at rest using dedicated encryption keys per tenant and encryption in transit using TLS. Dedicated per-tenant keys mean that a compromise of one tenant’s key does not expose another tenant’s data.

Multi-tenancy isolation: In a multi-tenant cloud platform, your data shares infrastructure with other customers. The critical question is whether isolation is logical or physical and whether it is sufficient for your risk tolerance. DnXT enforces tenant-level data isolation, ensuring that no user or process from one tenant can access another tenant’s data, configurations, or audit logs.

SOC 2 alignment: While SOC 2 is not a Part 11 requirement, it provides independent assurance of the vendor’s security controls. Ask whether the vendor has completed a SOC 2 Type II audit and request the report for your security team’s review.

Practical Advice: Questions to Ask Any Cloud Vendor

When evaluating a cloud-based regulatory platform for Part 11 compliance, these questions will separate vendors with genuine compliance posture from those with marketing claims:

• Can you provide your IQ/OQ documentation, and what does the customer need to produce for PQ? A vendor that has ready-to-use validation packages has been through this process with other regulated customers.
• How are audit logs stored, and can any user — including your own administrators — modify or delete them? The only acceptable answer is no.
• What happens to our data if we terminate the contract? You need a clear data export process and a documented destruction policy.
• How do you handle platform updates, and what is the revalidation impact on customers? Look for a vendor that can deploy updates without requiring customers to execute full regression testing.
• Can you provide a SOC 2 Type II report? If not, ask what third-party security assessments they have completed.
• Where is our data physically stored, and can you contractually guarantee data residency? Verbal assurances are not sufficient.
• How is tenant isolation enforced at the infrastructure, application, and data layers? A good vendor can explain this in detail without hesitation.

Cloud-based regulatory systems are not inherently less compliant than on-premise systems. In many cases, they offer stronger audit trail infrastructure, more consistent security controls, and more rigorous operational practices than what most organizations can maintain internally. The key is due diligence: evaluate the vendor’s compliance architecture with the same rigor you would apply to an on-premise system, and ensure that contractual commitments match technical capabilities. Your quality team does not need to be convinced that cloud is safe in the abstract — they need to see specific evidence that a specific platform meets specific Part 11 requirements. The right vendor will make that evidence easy to obtain.