Introducing GenRAC
Streamline Regulatory Compliance with GenRAC
Stop Reacting to Compliance. Start Shaping It. GenRAC is an innovative, 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.
Why GenRAC?
- 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.
Benefits of GenRAC
- 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.
Key Features of GenRAC
- 25 Regulatory Frameworks, One Dashboard: Manage HIPAA, GDPR, ISO 13485, NABH 6th Edition, cGMP, 21 CFR Part 11, DPDPA, SOC 2, and more (refer to the table below for other frameworks supported)—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
| Industry | US | EU | UK | India | CJK (China / Japan / Korea) | Global / International |
|---|---|---|---|---|---|---|
| Pharmaceuticals | FDA 21 CFR 210/211 (cGMP), DSCSA, FDCA, PDUFA | EMA, EU GMP (incl. Annex 1 & 11), Falsified Medicines Directive, CTR 536/2014 | MHRA, UK GMP | CDSCO, D&C Act 1940, Schedule M (revised), NDCT Rules 2019, DPDP Act 2023 | CN: NMPA, Drug Admin Law, China GMP, MAH system • JP: PMDA, MHLW, PMD Act, J-GMP (Ord. 179) • KR: MFDS, Pharmaceutical Affairs Act, KGMP | ICH (Q/E/S/M), WHO GMP, PIC/S, HL7 FHIR (medication resources, IDMP alignment) |
| CROs / Clinical Research | FDA 21 CFR Parts 11, 50, 54, 56, 312; HIPAA; Common Rule; FDA "Real-World Data" guidance (uses FHIR) | EU CTR 536/2014, CTIS, GDPR | MHRA, HRA, UK GDPR | NDCT Rules 2019, CDSCO, ICMR Ethical Guidelines, DPDP Act 2023 | CN: NMPA GCP, HGRA, PIPL • JP: J-GCP, Clinical Trials Act, APPI • KR: KGCP, Bioethics & Safety Act, PIPA | ICH-GCP E6(R3), Declaration of Helsinki, CIOMS, CDISC (SDTM/ADaM/CDASH), HL7 FHIR — Vulcan Accelerator (FHIR-to-CDISC mapping), ICH M11 (CeSHarP) leveraging FHIR |
| Healthcare Providers / Payers | HIPAA, HITECH, 21st Century Cures Act + ONC info-blocking rule (mandates HL7 FHIR R4 + USCDI), CMS Interoperability & Patient Access Rule (mandates FHIR APIs for payers), CMS-0057-F "Prior Authorization API" (FHIR-based, eff. 2026–27), HHS OCR, ICD-11 | GDPR, EHDS (mandates HL7 FHIR + IPS for EHR exchange across Member States), NIS2 | UK GDPR, NHS DSPT, CQC, NHS England FHIR UK Core profiles, NHS Digital APIs (FHIR R4) | Clinical Establishments Act 2010, NABH, IT Act 2000, DPDP Act 2023, ABDM — built on HL7 FHIR R4 (NDHM FHIR IG), SNOMED CT, LOINC, ICD-10 | CN: NHC regs, PIPL, DSL, CSL; FHIR adoption emerging via WeChat Health / hospital pilots • JP: Medical Care Act, APPI, SS-MIX2 (HL7 v2) transitioning to FHIR JP Core (JAHIS) • KR: Medical Service Act, PIPA, MyHealthWay platform (FHIR-based), EMR certification | HL7 FHIR R4 / R5 (core standard), HL7 v2/v3, International Patient Summary (IPS — ISO 27269, FHIR-based), SNOMED CT, ICD-10/11 (WHO), LOINC, IHE profiles (XDS, PIX/PDQ, MHD — Mobile access using FHIR), openEHR, ISO 27799, ISO 13606 |
| Medical Devices | FDA 21 CFR Part 820 → QMSR (eff. Feb 2026), UDI, 510(k)/PMA/De Novo; FDA pre-cert + SaMD guidance | EU MDR 2017/745, IVDR 2017/746, EUDAMED | UKCA, UK MDR 2002 | Medical Device Rules 2017, CDSCO licensing, DPDP Act 2023 | CN: NMPA, Order 739 (MDR), UDI, China GMP for devices • JP: PMD Act, PMDA, MHLW Ord. 169 (QMS), J-UDI • KR: MFDS, Medical Devices Act, KGMP for devices | ISO 13485, ISO 14971, IEC 62304, IEC 60601, DICOM (imaging devices), IEEE 11073 / Personal Connected Health Alliance (PCHA) Continua — maps to HL7 FHIR for device data, IMDRF, MDSAP |
| Hospitals | Joint Commission, CMS CoPs, HIPAA, EMTALA, ACR accreditation, MQSA (mammography), ONC-certified EHR (FHIR R4 APIs mandatory) | National frameworks + GDPR, EHDS (FHIR-based exchange) | CQC, NHS DSPT, RCR standards, IR(ME)R 2017, NHS FHIR UK Core, GP Connect (FHIR) | NABH, Clinical Establishments Act, PNDT Act, AERB (radiation safety), DPDP Act 2023, ABDM (FHIR R4-based health records, ABHA-linked) | CN: NHC, Hospital Accreditation Standards, PIPL • JP: Medical Care Act, JCQHC, JIRA, APPI, FHIR JP Core profiles (JAHIS) • KR: Medical Service Act, KOIHA accreditation, PIPA, MyHealthWay (FHIR) | JCI, ISO 9001, HL7 FHIR R4/R5, DICOM, PACS / VNA, HL7 v2, SNOMED CT, ICD-10/11, LOINC, IHE profiles (Radiology RAD-TF, PaLM, MHD-FHIR, PDQm/PIXm), ICRP / IAEA BSS |
| Diagnostic Labs | CLIA, CAP, HIPAA, LOINC mandated for lab orders/results, FHIR-based lab APIs under USCDI v3+ | IVDR 2017/746, GDPR | UKAS accreditation, MHRA | NABL (ISO 15189), ICMR, CDSCO (for IVDs), DPDP Act 2023, ABDM (FHIR R4 Diagnostic Report resource) | CN: NMPA (IVDs), CNAS accreditation, NHC clinical lab regs • JP: MHLW, PMD Act for IVDs, JCCLS • KR: MFDS, KOLAS / KLAP accreditation | ISO 15189, ISO/IEC 17025, LOINC, SNOMED CT, HL7 FHIR (DiagnosticReport, Observation, Specimen resources), HL7 v2 ORU messages, DICOM (digital pathology — Sup. 145), IHE PaLM, ICCR (cancer reporting) |
| Chemicals | TSCA, EPA, OSHA HazCom, EPCRA | REACH, CLP, Seveso III, BPR, POPs Reg | UK REACH, COSHH, COMAH | MSIHC Rules 1989, MoEFCC, CPCB, Chemical Weapons Convention Act | CN: MEE Order 12 ("China REACH"), GHS China, China RoHS 2 • JP: CSCL, ISHL, J-GHS, PRTR Law • KR: K-REACH, K-OSHA, K-BPR, CCA | GHS, Rotterdam / Stockholm / Basel Conventions, Montreal Protocol |
| Manufacturing | OSHA, EPA, FTC, CPSC | CE marking, Machinery Reg 2023/1230, RoHS, WEEE, REACH | UKCA, HSE | Factories Act 1948, BIS standards, MoEFCC, Labour Codes, EPR rules | CN: GB standards, MIIT, SAMR, CCC certification • JP: JIS, METI, ISH Act, PSE mark • KR: KS standards, KC certification, K-OSHA, MOEL | ISO 9001, ISO 14001, ISO 45001, ISO 50001 |
| Food & Beverages | FDA FSMA, FD&C Act, USDA FSIS, TTB | EU Food Law 178/2002, EFSA, FIC 1169/2011, Novel Foods Reg | FSA, FSS (Scotland) | FSSAI, FSS Act 2006 & Regulations, DPDP Act 2023 | CN: Food Safety Law, SAMR, GB food standards, GACC import rules • JP: Food Sanitation Act, MHLW, JAS, Food Labelling Act • KR: MFDS, Food Sanitation Act, KFDA labelling | Codex Alimentarius, HACCP, ISO 22000, GFSI (BRCGS, SQF, FSSC 22000) |
| Cosmetics | FDA MoCRA 2022, FD&C Act, FTC | EU Cosmetics Reg 1223/2009, CPNP | UK Cosmetics Reg, SCPN | D&C Act 1940 + Cosmetics Rules 2020, BIS, CDSCO, DPDP Act 2023 | CN: NMPA, CSAR 2021, Toothpaste Supervision Regs • JP: PMD Act (quasi-drugs & cosmetics), MHLW, JCIA • KR: MFDS, Cosmetics Act, K-Cosmetic GMP | ISO 22716 (Cosmetics GMP), ASEAN Cosmetics Directive |
| General | SOC2 Type 1 and 2, NIST CSF2.0, Baldrige Excellence Framework | |||||
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.
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Contact us for more information about GenRAC and how it can transform your compliance processes at gbc@genbioca.com