Skip to main content

Fully compliant platform for regulated clinical research

ACAM is built for privacy, security, data integrity, electronic record traceability, auditability, and validation-aware clinical operations.

GDPR Compliant HIPAA Compliant FDA 21 CFR Part 11 NIST CSF-Aligned AWS Cloud-Native

Built for regulated clinical workflows

GDPR Compliant

Privacy-conscious processing, controlled access, secure data handling, and traceability for personal data workflows.

HIPAA Compliant

Safeguards for PHI, secure access, operational logging, and healthcare data protection workflows.

FDA 21 CFR Part 11

Electronic record traceability, audit trails, user accountability, controlled workflows, and validation-aligned practices.

NIST CSF-Aligned

Security controls mapped to Identify, Protect, Detect, Respond, and Recover.

Traceability from action to record

ACAM preserves user accountability and electronic record traceability across capture, import, processing, review, queries, and adjudication.

User Action Capture, import, review
Time Stamp Precise event recording
Record Version Change tracking
Audit Entry Immutable log
Review / Approval Decision traceability
Audit Trail — PT-0142-W12 21 CFR Part 11
Timestamp User Action Ver
2024-03-15 09:14 J. Chen Session created 1.0
2024-03-15 09:38 J. Chen Recording uploaded 1.1
2024-03-15 10:02 System Transcript generated 1.2
2024-03-15 14:20 S. Mitchell Review started 1.2
2024-03-15 15:45 S. Mitchell Query opened 1.3

Security controls aligned to clinical operations

Access

Role-based accessUnique user accountsLeast-privilege model

Data

Encrypted storageSecure processingData minimization

Monitoring

Audit logsAccess logsProcessing events

Response

Incident workflowsSupport escalationOperational triage

Recovery

Backup processesRestoration validationCloud durability

NIST CSF-aligned security governance

Identify

Map systems, data, users, and study context.

Protect

Apply access control, encryption, and least-privilege operations.

Detect

Monitor logs, audit trails, activity, and processing events.

Respond

Support triage, escalation, and incident response workflows.

Recover

Support backup, restoration, and recovery validation practices.

Cloud-native on AWS

ACAM uses AWS cloud services to support scalable storage, processing, delivery, monitoring, and secure operations for regulated clinical workflows.

Secure storage Media processing Transcription Document extraction CDN playback Monitoring Infrastructure as code

Designed for validation-aware teams

ACAM is developed and operated with regulated software lifecycle expectations in mind, supporting documentation, traceability, controlled change, and release evidence.

SRS
FRS
UFRS
SDS
CS
IQ
OQ
PQ
Release Log
VSR

Ready to modernize clinical assessment data capture?

See how ACAM helps your team capture new clinical data, import existing study media, process recordings and documents, support reviewers, and maintain compliance across regulated study workflows.