Regulatory Compliance Mapping
Ensure regulatory compliance with automated mapping to GxP, HIPAA, and FDA 21 CFR Part 11 using controlled vocabularies and continuous monitoring for life sciences organizations.
Compliance Complexity
Life science organizations struggle with complex regulatory requirements, manual compliance tracking, and audit preparation consuming valuable resources.
Manual compliance tracking across regulations
Weeks of audit preparation and documentation
Risk of compliance violations and penalties
Automated Compliance
Transform your compliance posture with automated mapping, continuous monitoring, and intelligent alerting that keeps you audit-ready at all times.
Reduce audit preparation time by 70%
Eliminate compliance violations with automated monitoring
Streamline regulatory submissions and reporting
Maintain continuous compliance posture
Comprehensive Coverage
Complete regulatory compliance suite
Advanced tools for maintaining compliance across all major life sciences regulations
- GxP Compliance Mapping
Automatically map your processes and data to GxP requirements with built-in validation and audit trails.
- FDA 21 CFR Part 11
Ensure electronic records and signatures meet FDA requirements with comprehensive compliance controls.
- Risk Assessment
Identify compliance risks early with automated monitoring and intelligent alerting systems.
- Real-Time Monitoring
Continuous compliance monitoring with real-time notifications and automated reporting.
Supported Regulations
Major life sciences compliance frameworks
FDA 21 CFR Part 11
Electronic records and electronic signatures compliance for pharmaceutical manufacturing.
HIPAA
Healthcare data privacy and security requirements for patient information protection.
GxP Guidelines
Good practice guidelines for pharmaceutical quality management systems.
ICH Guidelines
International harmonization standards for pharmaceutical development and registration.
Ready to Automate Your Compliance?
Join life science organizations who have reduced audit preparation time by 70% with GraphFlux Regulatory Compliance Mapping.