Compliance & Security
Everything we build follows a compliance-first engineering process. HIPAA, CLIA, and FDA Part 11 controls are embedded into how we work — not bolted on after the fact.
HIPAA Compliance
Every Gistia engagement includes a Business Associate Agreement (BAA). Our engineering process implements all three categories of HIPAA safeguards across every automation.
Administrative Safeguards
- Security management process with risk analysis
- Workforce training and awareness programs
- Information access management policies
- Security incident response procedures
- Contingency planning and disaster recovery
- Business Associate Agreements on all engagements
Physical Safeguards
- Facility access controls via cloud provider (AWS)
- Workstation security policies
- Device and media disposal procedures
- Environmental controls and monitoring
Technical Safeguards
- AES-256 encryption at rest and in transit
- Unique user identification and authentication
- Automatic session timeout and lockout
- Audit controls and access logging
- Data integrity verification
- Transmission security (TLS 1.2+)
CLIA Compliance
Laboratory automations include CLIA-specific process controls for quality management, personnel competency, and specimen integrity.
Quality Control (QC) Checkpoints
Every laboratory automation includes mandatory QC steps. Results cannot be released without passing defined quality thresholds.
Proficiency Testing Integration
Automated proficiency testing workflows with scheduling, result submission, and corrective action tracking.
Personnel Competency Tracking
Track training, certifications, and competency assessments for all personnel interacting with regulated processes.
Specimen Tracking & Chain of Custody
End-to-end specimen tracking from collection to result, with complete chain of custody documentation.
Calibration & Maintenance Records
Automated tracking of instrument calibration schedules, maintenance logs, and out-of-range alerts.
Process Documentation
Auto-generated SOPs, method validation records, and procedure change documentation with full version history.
FDA 21 CFR Part 11
For pharmaceutical, CRO, and FDA-regulated environments, the platform includes Part 11 controls for electronic records and electronic signatures.
Electronic Signatures (21 CFR 11.50-11.100)
Legally binding electronic signatures with signer identification, meaning statement, and timestamp for every signature event.
Audit Trails (21 CFR 11.10(e))
Secure, computer-generated, time-stamped audit trails recording the date, time, operator, and action for every record creation, modification, or deletion.
System Validation (21 CFR 11.10(a))
IQ/OQ/PQ validation documentation auto-generated for every automation deployment, with traceability to requirements.
Access Controls (21 CFR 11.10(d))
System access limited to authorized individuals. Role-based permissions with separation of duties for critical operations.
Operational Checks (21 CFR 11.10(f))
Automated checks to enforce permitted sequencing of steps and events. Invalid operations are blocked and logged.
Record Retention (21 CFR 11.10(c))
Electronic records protected against unauthorized modification, retained for required periods, and available for regulatory inspection.
Questions About Compliance?
Our team can walk you through our compliance controls and discuss how our engineering process meets your specific regulatory requirements.