GenRAC — Regulatory Compliance Automation
Your next audit should not be a crisis
Hospitals, pharma companies, and insurers spend months preparing for NABH, DPDPA, and other regulatory audits — manually, repeatedly, and at enormous cost. GenRAC turns compliance from a fire drill into a continuous, automated function.
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The GenBioCa Managed Service Guarantee:
Every GenRAC deployment is backed by our compliance specialists. If your organisation enters an audit cycle and GenRAC has not achieved a defined readiness threshold agreed at onboarding, we extend managed services at no additional cost until you do.
THE PROBLEM
- Compliance is broken — and everyone knows it
- Most healthcare and pharma organisations treat regulatory compliance as a once-a-year sprint. The result is chronic gaps, audit anxiety, and compliance teams perpetually firefighting instead of governing.
- Evidence collection is entirely manual:
Teams scramble across departments, chasing documents, photos, and logs — weeks before every inspection. The same work repeats for every audit cycle with no institutional memory. - Gaps surface only during the audit:
Without continuous monitoring, critical compliance failures are invisible until an inspector flags them. By then, the cost — in penalties, remediation, and reputation — is already high. - No single source of compliance truth:
Rules live in PDF circulars. Evidence sits in email threads. Status updates are buried in spreadsheets. Nobody has a reliable, real-time view of where the organisation actually stands. - Frameworks change; teams don't know:
NABH updates criteria. DPDPA 2025 introduces new data obligations. Internal teams rarely have the bandwidth to track regulatory changes and re-map them to operational controls in time.
WHAT GENBIOCA GUARANTEES
- Compliance readiness, year-round — not a sprint before inspection
- GenRAC is built around outcomes, not features. When you work with GenBioCa, these are the commitments we make — backed by our managed service.
- 90 days to first audit-ready state
- 24 hours gap detection to assignment
- 0 manual evidence collections at audit time
HOW GENRAC DELIVERS IT
- Six layers working continuously, so your team doesn't have to
- GenRAC isn't a checklist tool. It's a compliance operating system — from rule ingestion through evidence management, gap detection, and audit-day reporting.
- 1. Rules Engine — 3,285 pre-loaded standards-
Every NABH criterion (SHCO and HCO), DPDPA 2025 data obligation, and supported framework is pre-loaded, versioned, and updated when regulations change. Your team never reads a regulatory circular to extract a rule. - 2. Continuous Monitoring — live compliance scoring
GenRAC polls your linked systems and evidence repositories on a defined schedule, computing a real-time readiness score by standard, department, and site. Your compliance posture is always current — not a six-month-old snapshot. - 3. Evidence Management — 700+ templates, auto-linked Each rule maps to a pre-built evidence template. Teams upload, tag, and version-control documents against specific standards. GenRAC validates completeness, flags expiry dates, and maintains an audit-ready evidence pack at all times.
- 4. Gap Intelligence — auto-assign, auto-escalate When a gap is detected, GenRAC identifies the owning department, assigns the task with a deadline, and escalates if unresolved within the SLA. Nothing falls through the cracks because there is no manual handoff.
- 5. Multi-site & Multi-framework — one view Manage NABH compliance across multiple hospitals or clinics simultaneously. Different frameworks, different sites, different audit timelines — all unified in a single compliance workspace with role-based access per facility.
- 6. Audit Pack Generation — one-click, inspection-ready On demand, GenRAC generates a complete, formatted audit submission package — evidence mapped to standards, indexed, and structured to the inspector's expected format. No assembly, no last-minute panic.
Built for regulated industries with high-stakes inspection cycles
| Hospitals & Clinics | Pharma & Life Sciences | Insurers & TPAs |
|---|---|---|
| NABH accreditation and re-accreditation for HCO (multi-specialty) and SHCO (small healthcare) organisations. Manage evidence, departmental controls, and staff competency records. | Quality management and data compliance for pharmaceutical manufacturers, CROs, and life sciences organisations. Map SOPs, batch records, and data governance obligations. | IRDAI compliance and data protection for health insurers and third-party administrators. Automate policy documentation, grievance records, and regulatory returns. |
| NABH HCO · NABH SHCO · DPDPA 2025 · Clinical Audit | GxP Compliance · 21 CFR Part 11 · DPDPA 2025 · Internal QMS | IRDAI · DPDPA 2025 · Claims Audit |
For those who want to know what's under the hood
GenRAC is a production-grade, full-stack SaaS platform built for reliability, security, and regulatory-grade auditability.
- Rules & Framework Engine
● Framework taxonomy: Framework → Standard → Criterion → Evidence Requirement, with criticality and renewal frequency metadata at every node.
● Every regulatory update is versioned — historical compliance states are preserved for post-audit reviews.
● Full NABH SHCO and HCO criterion coverage; 700+ Word evidence templates pre-mapped to each standard.
● 109 DPDPA 2025 templates covering Data Fiduciary obligations, consent management, breach notification, and grievance officer requirements. - Evidence & Document Management
● Every evidence requirement maps to a pre-built, structured template with completeness validation before acceptance.
● All uploaded evidence is version-controlled with timestamped, immutable change logs and user attribution.
● Expiry and renewal tracking for licenses, certifications, and staff training records — with configurable escalation windows.
● Bulk upload and migration support; GenBioCa's onboarding team handles initial load for Managed Service clients. - Monitoring, Scoring & Alerting
● Weighted compliance score calculated continuously at standard, chapter, framework, and site level.
● Gap detection engine executes on a configured schedule; gaps flagged immediately with severity classification and owner assignment.
● Alerts route via in-platform notifications and email, with configurable escalation paths per standard, department, or site.
● Trend and historical analytics expose systematic weaknesses across departments and audit cycles. - Infrastructure & Security
● Full-stack monorepo: NestJS · React/Vite · PostgreSQL · Drizzle ORM · pnpm.
● Production infrastructure: Ubuntu server · Nginx · PM2 · SSL/TLS · 130+ REST endpoints.
● Dedicated client infrastructure with full isolation. ISO 27001:2022 certified. CMMI Level 3 SVCS.
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 | |||||
Ready to make compliance a continuous function?
Talk to a GenBioCa compliance specialist. We'll assess your current readiness, identify your highest-risk gaps, and show you exactly how GenRAC closes them — in one working session.
Contact us for more information about GenRAC and how it can transform your compliance processes