How can ManageEngine support 21 CFR Part 11 compliance?
With ManageEngine AD360 & Log360, organizations can align with 21 CFR Part 11 requirements through centralized identity and access management and strong authentication mechanisms including MFA, detailed audit trails of user activities, real-time monitoring of system access and changes, and secure log management. These capabilities help ensure data integrity, enforce accountability, and provide comprehensive reporting to meet regulatory and audit expectations.
§ 11.10 Controls for closed systems
| Clause | Functionality | Explanation |
|---|---|---|
| Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. | Log360 - Centralized log management, real-time security analytics, compliance templates, alerts, file integrity monitoring, and audit trails | Log360 is directly aligned to the closed-system control model by centralizing monitoring, preserving audit history, flagging unauthorized activity, and supporting integrity/confidentiality oversight across regulated infrastructure. These capabilities materially support authenticity, integrity, confidentiality, and non-repudiation evidence. |
| (a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. | Log360 - File integrity monitoring, anomaly detection, centralized monitoring, and correlation rules | Log360 helps organizations detect altered records, suspicious changes, and inconsistent operational behavior through integrity monitoring and analytics. It provides evidence useful in validation and ongoing control verification. |
| (b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. | Log360 - Searchable log repository, exportable reports, scheduled reports, and compliance templates | Log360 supports accurate and complete evidence production through searchable centralized records and exportable human-readable reports, alongside electronic output suitable for inspection, review, and copying. |
| (c) Protection of records to enable their accurate and ready retrieval throughout the records retention period. |
Log360 - Log retention, centralized storage and search. AD360-linked backup/retention support for platform records |
Log360 preserves records for later retrieval through centralized storage and retention-focused log management. Within the broader suite selection, related backup/retention capabilities further support long-term recoverability of regulated evidence. |
| (d) Limiting system access to authorized individuals. | AD360 - Role-based access management, OU-based delegation, access certification, MFA, conditional access, SSO | AD360 directly aligns by enforcing authorized access through role-based administration, delegated boundaries, access reviews, MFA, and conditional access controls for identity-driven systems. |
| (e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying. | Log360 - Comprehensive audit trail, time-stamped logs, retention, real-time alerts, andsearchable archive | Log360 centrally records time-stamped user and system activity, preserves prior-event history, supports retention, and makes the trail available for review, search, and export. |
| (f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate. | AD360 - Approval-based workflow, multi-step orchestration, and delegated task control | AD360 supports permitted sequencing through approval-based workflows and orchestration so that requests can follow defined stages such as request, approval, execution, and verification. |
| (g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand. | AD360 - Role-based access management, delegation, access certification, MFA, and privileged access governance | AD360 is directly aligned to authority checks by enforcing role-scoped administration, periodic access certification, and strong authentication before sensitive operations are executed. |
| (h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction. | AD360 - Endpoint MFA, device-based MFA, conditional access, and phishing-resistant authenticators | AD360 contributes to source-validity assurance through endpoint MFA, device-aware authentication, and strong authenticators that help verify that operational instructions originate from a trusted user/device context. |
| (k)(2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation. | Log360 - Time-stamped audit trails, change monitoring, and alerting | Log360 provides time-sequenced audit evidence for changes occurring in monitored systems and can support documentation-change oversight where those repositories emit auditable events. |
§ 11.30 Controls for open systems
| Clause | Functionality | Explanation |
|---|---|---|
| Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt. Such procedures and controls shall include those identified in § 11.10, as appropriate, and additional measures such as document encryption and use of appropriate digital signature standards to ensure, as necessary under the circumstances, record authenticity, integrity, and confidentiality. |
AD360 - MFA, SSO, conditional access, biometrics. Log360-aligned monitoring in the combined suite |
For open-system exposure, AD360 contributes strong identity assurance through MFA, biometrics, SSO, and conditional access, while the combined suite can monitor events centrally. These controls materially improve authenticity and confidentiality across distributed access scenarios. |
§ 11.100 General requirements
| Clause | Functionality | Explanation |
|---|---|---|
| (a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else. | AD360 - Unique user identities, life cycle governance, MFA, access certification | AD360 directly supports uniqueness and non-reassignment through identity life cycle governance, unique directory identities, and controlled authentication and review processes. |
| (b) Before an organization establishes, assigns, certifies, or otherwise sanctions an individual's electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual. | AD360 - identity governance, MFA enrollment, self-service identity security controls | AD360 supports stronger identity assurance by governing user identities and MFA enrollment and by centralizing identity-centric controls before sensitive access is granted. |
§ 11.200 Electronic signature components and controls
| Clause | Functionality | Explanation |
|---|---|---|
| (a)(1) Employ at least two distinct identification components such as an identification code and password. | AD360 - MFA, two-factor authentication, FIDO2/passwordless, biometrics, and smart card/YubiKey support | AD360 directly aligns by supporting MFA with at least two distinct components, including password-plus-second-factor and phishing-resistant methods. |
§ 11.300 Controls for identification codes/passwords
| Clause | Functionality | Explanation |
|---|---|---|
| (a) Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination of identification code and password. | AD360 - Unique directory identities, password policy enforcement, and life cycle governance | AD360 supports unique identity issuance and password governance so that credentials remain user-specific and controlled through the identity life cycle. |
| (b) Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging). | AD360 - Password expiry notifier, password policy enforcer, self-service reset, and password synchronization | AD360 directly aligns by enforcing password policies, notifying users of password expiry, and supporting controlled password reset/change processes across connected systems. |
| (c) Following loss management procedures to electronically deauthorize lost, stolen, missing, or otherwise potentially compromised tokens, cards, and other devices that bear or generate identification code or password information, and to issue temporary or permanent replacements using suitable, rigorous controls. | AD360 - MFA administration, self-service credential recovery, and conditional access | AD360 contributes by supporting credential recovery and MFA administration, which can be incorporated into procedures for deauthorizing compromised authenticators and restoring access in a controlled manner. |
| (d) Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and report in an immediate and urgent manner any attempts at their unauthorized use to the system security unit, and, as appropriate, to organizational management. | Log360 - Real-time alerts, security analytics, anomaly detection, unauthorized-access monitoring, instant notifications | Log360 is strongly aligned to the detection-and-reporting side of this clause through real-time analytics and immediate alerts for unauthorized access attempts, suspicious authentication activity, and policy violations. |
| (e) Initial and periodic testing of devices, such as tokens or cards, that bear or generate identification code or password information to ensure that they function properly and have not been altered in an unauthorized manner. | AD360 - MFA device enrollment and authentication oversight | AD360 provides oversight over factor enrollment and usage, which can support a broader control program around authenticator health and integrity. |
Conclusion
Now that you’ve explored how 21 CFR Part 11 establishes strict requirements for electronic records and signatures, and how AD360 & Log360 can help support these requirements, it’s time to take the next step.
Whether it’s identity governance, secure access controls, audit trail management, or real-time monitoring to maintain data integrity, we’re here to guide you through it. Start a 30-day free trial to experience our solutions in your own environment, or contact us to schedule a one-on-one consultation.
Disclaimer: The information provided on this page is for general knowledge and awareness purposes only. It is not intended to serve as professional, legal, or regulatory advice. Compliance with 21 CFR Part 11 depends on your organization’s specific systems, processes, and validation requirements.
To assess your compliance posture accurately, we strongly recommend engaging a qualified consultant, compliance expert, or referring directly to official FDA guidelines and documentation.