Streamline Regulatory Compliance with GenRAC from GenBioCa
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 Pharmaceutical and Life Sciences clients, Healthcare industries, Clinical Research centres, and Contract Research Organizations. Developed by GenBioCa’s domain experts, GenRAC transforms compliance from a manual burden into a proactive, "First Time Right" strategic asset.
Whether you are a 50-bed hospital seeking NABH accreditation or a multinational pharmaceutical company managing cGMP, 21 CFR Part 11, and GDPR simultaneously, GenRAC delivers continuous audit readiness from a single platform.
- Minimize Massive Financial Risk: Adhere to global standards like HIPAA, GDPR, ISO 13485, and SOC2 to mitigate penalties that can reach $1.5 million per incident or €20 million.
- Eliminate "Hundreds of Hours Lost": Replace fragmented spreadsheets and manual checklists with a unified system that reduces the person-hours typically consumed by audit cycles.
- Single Source of Truth: Centralize evidence that is often scattered across drives and inboxes, ensuring it is instantly retrievable during inspections.
- AI-Powered Insights: Utilize Generative AI (via AWS Bedrock) to analyse evidence, generate compliance scores, and identify gaps in minutes rather than weeks.
- Efficiency: Dramatically reduce time spent on manual compliance and audit preparation.
- Accuracy: Ensure First Time Right (FTR) compliance across all regulatory filings, including NDA/ANDA and e-CTD submissions.
- Scalability: Adaptable plans ranging from Starter (4 users) to Enterprise (Unlimited/White-label) with deployment options on AWS SaaS or private on-premises via Docker/Kubernetes.
- AI-Powered Insights: Utilize Generative AI (via AWS Bedrock) to analyse evidence, generate compliance scores, and identify gaps in minutes rather than weeks.
- 21+ Regulatory Frameworks, One Dashboard: Manage HIPAA, GDPR, ISO 13485, NABH 6th Edition, cGMP, 21 CFR Part 11, DPDPA, SOC 2, EU MDR, and more from a single pane of glass.
- Proprietary Unified Taxonomy: Map a single piece of evidence across multiple frameworks simultaneously to eliminate redundant assessments.
- "Uberized" Auditor Marketplace: Access internal audits, fully automated AI audits, or browse our marketplace of certified external auditors by specialization and rating.
- Risk Quantification in Real Currency: View compliance gaps as financial risk in INR or USD. Use the "What-If" analyser to see exactly how process improvements reduce penalty risks.
- Automated CAPA Lifecycle: Auto-generate Corrective and Preventive Actions from findings with root cause analysis tools (5 Whys, Fishbone, FMEA) and SLA-driven escalation.
- Built-in 21 CFR Part 11 Compliance: Features an immutable, hash-chained audit trail with digital signatures and mandatory reason capture—your compliance tool is itself compliant.
- Enterprise-Grade Security: AES-256 encryption, TLS 1.2+, and data localization for DPDPA compliance.
Who Can Benefit & The Frameworks Covered
- Pharmaceutical & Biotech- cGMP, 21 CFR Part 11, GLP, GAMP 5, ICH E6 GCP
- Hospitals & Healthcare- NABH 6th Ed, HIPAA, DPDPA, FHIR, SNOMED/DICOM
- Medical Devices- ISO 13485, EU MDR, IEC 62304, REACH/GHS
- Clinical Research Organisation (CRO)- ICH E6 GCP, GLP, 21 CFR Part 11, CDISC/SDTM
- Health Insurance & Payers- HIPAA, SOC 2, HITRUST CSF, GDPR
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?
Contact us for more information about GenRAC and how it can transform your compliance processes or contact our team at gbc@genbioca.com