PHARMACEUTICAL & LIFE SCIENCES
Your CROs and CRAs access clinical trial systems from devices your IT has never touched.
FDA Part 11 requires documented audit trails. Ensure verifies device compliance at every access event without MDM enrollment.
FDA Part 11No MDM RequiredGxP Compatible
Regulatory framework mapping
How Ensure maps to the compliance frameworks that matter in life sciences.
| Framework | Requirement | What Ensure Documents |
|---|---|---|
| FDA 21 CFR Part 11 | Access controls and audit trails for systems producing electronic records. | Device posture verified at login. Timestamped audit record created. |
| EU Annex 11 | Validated access controls for computerised systems in clinical environments. | Access controls extended to unmanaged devices without MDM. |
| GxP | Documented controls over system access, including external users. | Continuous posture verification with exportable compliance evidence. |
| HIPAA | Access controls and audit controls for ePHI systems. | Encryption, antivirus, and firewall verified before ePHI access. |
Key contractor populations
Clinical Research Associates (CRAs)
Field-based CRAs access EDC systems and safety databases from personal laptops. Ensure verifies posture without MDM.
Contract Research Organizations (CROs)
CRO staff access sponsor systems for data entry and reporting. Ensure provides the device compliance evidence sponsors need.
Contract Manufacturing (CMOs)
Manufacturing partners access quality systems and batch records. Ensure verifies device security before system access.
Need exportable evidence for FDA Part 11 audits?
See Compliance EvidenceSee how Ensure supports life sciences compliance
Book a demo to review compliance reporting for FDA Part 11, GxP, and HIPAA.