Streamline Regulatory Compliance with GenRAC
Stop Reacting to Compliance. Start Shaping It. GenRAC is an innovative, AI-powered compliance automation platform designed to streamline, automate, and enforce compliance processes for Life Sciences & Healthcare organisations. Built by GenBioCa’s domain experts, GenRAC transforms compliance from a manual burden into a proactive, data-driven strategic asset.
Operating under the world's most stringent regulatory environments, GenRAC ensures "First Time Right" (FTR) compliance, providing your path to continuous audit readiness.
- Minimize Massive Financial Risk: Mitigate risks associated with HIPAA penalties (up to Rs. 12.5 Cr), India's DPDPA (up to Rs. 250 Cr), and GDPR fines (exceeding EUR 20 million).
- 3-Layer Compliance Enforcement Engine: Unlike platforms that only track rules, GenRAC enforces them through real-time interceptors, scoring engines, and sentinel monitoring that auto-detects violations before they become audit findings.
- Eliminate "Hundreds of Hours Lost": Achieve an 80% reduction in audit preparation time by replacing manual checklists and fragmented spreadsheets with 3,285 prepopulated regulatory rules.
- Quantified Risk in Real Currency: Translate non-compliance into direct financial exposure in INR, enabling management to prioritize remediation based on actual penalty risk.
- Efficiency: Dramatically reduce time spent on manual compliance and audit documentation.
- Accuracy: Ensure First Time Right (FTR) compliance across critical tasks and regulatory filings like NDA/ANDA and e-CTD submissions.
- Scalability: Multi-tenant architecture supporting 1,000+ concurrent users with a 4-level organizational hierarchy.
- Flexible Deployment: Fully managed SaaS on AWS (Mumbai region for DPDPA residency) or private on-premises deployment via Docker and Kubernetes.
- 25 Regulatory Frameworks, One Dashboard: Manage HIPAA, GDPR, ISO 13485, NABH 6th Edition, cGMP, 21 CFR Part 11, DPDPA, SOC 2, and more—all from a single, unified dashboard.
- Sentinel Engine (24/7 Monitoring): Automated checks run every 15 minutes to detect overdue CAPAs, expiring evidence, score degradation, and repeat non-conformities.
- AI-Powered Evidence Analysis: Utilizing AWS Bedrock, the platform analyses uploaded documents against regulatory rules to automatically set compliance levels and identify gaps.
- Automated CAPA Lifecycle: Auto-generate Corrective and Preventive Actions with root cause analysis tools (5 Whys, Fishbone, FMEA) and Sentinel auto-escalation to supervisors and admins.
- Evidence-Based Scoring: A proprietary unified taxonomy maps a single piece of evidence across multiple frameworks simultaneously, eliminating redundant assessments.
- Self-Service Knowledge Bank: A comprehensive FAQ and knowledge base searchable by framework, chapter, and rule to accelerate team onboarding.
- Built-in 21 CFR Part 11 Compliance: Features an immutable, hash-chained audit trail with HMAC-SHA256 digital signatures and full data modification logging.
Who Can Benefit & The Frameworks Covered
- Pharmaceutical & Biotech- cGMP (64 rules), 21 CFR Part 11 (41), GLP (44), GAMP 5 (40)
- Hospitals & Healthcare- NABH 6th Ed (623 OEs), HIPAA (402), DPDPA (123), FHIR (301)
- Medical Devices-ISO 13485 (78), EU MDR (155), MDSAP (202), CE Marking (50)
- Clinical Research Organisation (CRO)-ICH E6 GCP (57), GLP (44), 21 CFR Part 11 (41), CDISC (301)
- Health Insurance & Payers- SOC 2 (151), WCAG/ADA (86), GDPR (99), DPDPA (123)
Why Choose GenRAC?
GenRAC is developed by GenBioCa, leveraging years of expertise in regulatory compliance for highly regulated industries. With a focus on innovation and excellence, GenRAC provides:
- A robust platform to minimize compliance risks.
- A strategic approach to optimize regulatory operations.
- Tools to ensure adherence to the highest standards of quality and safety.
Ready to Transform Your Compliance Journey?
Schedule
a personalized demo and see GenRAC in action
with your own regulatory
frameworks.
Contact us for more information about GenRAC and how it can transform your compliance processes at gbc@genbioca.com