PHARMACEUTICAL & LIFE SCIENCES
Your CROs and CRAs use devices your IT has never touched.
FDA Part 11 requires documented audit trails. PosturePass checks the device at every login. No MDM.
FDA Part 11No MDM RequiredGxP Compatible
Regulatory framework mapping
How PosturePass maps to the compliance frameworks that matter in life sciences.
| Framework | Requirement | What PosturePass 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. PosturePass verifies posture without MDM.
Contract Research Organizations (CROs)
CRO staff access sponsor systems for data entry and reporting. PosturePass provides the device compliance evidence sponsors need.
Contract Manufacturing (CMOs)
Manufacturing partners access quality systems and batch records. PosturePass verifies device security before system access.
Need exportable evidence for FDA Part 11 audits?
See the compliance evidenceSee FDA Part 11 evidence generated for a CRO device, live.
Real device, real check, exportable audit trail in 15 minutes.