Best Of Your Growth, Our Mission
Digitally Engineered for
Inspection-Readiness
Compliance isn’t a checkbox. In life sciences, it’s a foundational pillar — governing how data is captured, how systems are validated, and how decisions are defended. At Agile Genix, we deliver compliance-first digital solutions that not only meet regulatory standards but automate and streamline them across your enterprise.
Whether you operate in clinical trials, pharmacovigilance, manufacturing, or healthcare delivery, our systems are designed to align with global frameworks like FDA 21 CFR Part 11, GxP, HIPAA, and GDPR — without slowing you down.
Our Compliance Engineering Services
Digital Validation & Computerized System Compliance
- Risk-based validation planning (based on GAMP 5)
- Computer System Validation (CSV) lifecycle automation
- IQ/OQ/PQ documentation templates and traceability
- Vendor audit support for SaaS and cloud platforms
- Change management aligned with GxP regulations
Outcome: Audit-ready validation processes that reduce human effort and accelerate time to deployment.
21 CFR Part 11 & Annex 11 Compliance
- Electronic signature and record management solutions
- Access control, versioning, and audit trail configuration
- System controls for time-stamping, locking, and archiving
- Gap assessments and remediation roadmaps
Outcome: Digitized record-keeping systems aligned with global regulatory requirements for electronic data integrity.
Regulatory Workflow Automation
- Automated deviation, CAPA, and non-conformance systems
- Electronic document management system (EDMS) configuration
- Role-based routing and escalation of regulatory tasks
- eTMF integrations for clinical documentation and trial records
Outcome: Faster response times, reduced manual intervention, and streamlined compliance across departments.
Privacy, Data Protection & Global Compliance
- HIPAA compliance for patient health information (PHI)
- GDPR compliance for EU clinical and commercial operations
- Consent management and subject rights handling
- Data anonymization and pseudonymization pipelines
- Cross-border data transfer governance
Outcome: Regionally aligned compliance infrastructure that protects patient data and reduces regulatory risk.
Compliance Frameworks We Align To
Our cloud frameworks are designed for compliance with:
- FDA 21 CFR Part 11
- EMA Annex 11
- GxP (GMP, GLP, GCP)
- GAMP 5
- HIPAA
- GDPR
- ISO 9001 & ISO 27001
- ICH E6(R2), E8, E9, E19
Why Agile Genix?
Domain-Led Compliance Expertise
Our compliance engineers and consultants understand both the technical infrastructure and the regulatory expectations behind it — from lab systems to eClinical tools.
- Automation-First Mindset
We move your compliance from manual to intelligent — reducing overhead, delays, and the risk of human error.
- Audit-Proven Track Record
Our clients have passed FDA, EMA, and sponsor inspections with zero critical observations — supported by systems we designed.
- Technology-Neutral Delivery
We integrate with Veeva Vault, MasterControl, TrackWise, and other industry-leading platforms — or build custom frameworks from the ground up
Success Delivered
Reduced validation documentation efforts by 60% via templated lifecycle management
Integrated EDMS and eTMF platforms across 4 global CRO divisions
Enabled HIPAA + GDPR-compliant infrastructure for cross-border clinical trial operations
Delivered Part 11–validated SaaS platform used by 100+ study sites globally
Let’s Engineer Your Compliance Advantage
n life sciences, being compliant isn’t enough — you need to be efficient, inspection-ready, and future-proof. Partner with Agile Genix to operationalize regulatory excellence at every layer of your tech stack.