✅ Regulatory Quality Engine

SKCore Compliances

NABH, NABL, CDSCO, DPDP, QOPI — audit-ready, always.

The regulatory backbone — automated accreditation checklists, CDSCO SaMD documentation, DPDP Act compliance tracking, QOPI quality measure reporting, and NCG/ICMR guideline integration with audit-ready exports at any time.

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Key Capabilities

What SKCore Compliances Does

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NABH Accreditation Checklists

Standard-by-standard NABH checklist with evidence attachment, responsible person assignment, and completion tracking. Auto-generated gap report.

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NABL Laboratory Compliance

ISO 15189 standard checklist for lab accreditation. QC documentation, PT/EQA records, corrective action logs, and internal audit tools.

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CDSCO SaMD Documentation

Software as Medical Device technical documentation support — risk classification, intended use, clinical evaluation template, and post-market surveillance log.

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DPDP Act 2023 Tracking

Consent register, data localisation evidence, breach notification log (72-hr CERT-In), and individual rights request management.

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QOPI Quality Measures

ASCO QOPI measure automation across quality indicators. eCQM electronic reporting. Network-level benchmarking.

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NCG & ICMR Guidelines

National Cancer Grid protocol integration with guideline cross-references. ICMR ethical research compliance documentation.

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Audit-Ready Export

One-click audit pack — evidence bundle, checklist completion status, corrective action register, and compliance score report in PDF.

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Compliance Alert Management

Upcoming accreditation renewal alerts, regulatory deadline tracking, standard revision notifications, and corrective action escalations.

AI Integration

AI in SKCore Compliances

AI in Compliances automates evidence mapping — linking clinical activities to compliance requirements and identifying gaps proactively.

  • ✓Automatic evidence mapping — activities to NABH standards
  • ✓Gap identification before accreditation survey
  • ✓Corrective action plan draft generation (advisory)
  • ✓QOPI measure auto-calculation from clinical data
  • ✓Regulatory document review for completeness
AI Governance Principles
✓Advisory only — AI suggests, clinician decides
✓PHI de-identified before every model call
✓Every suggestion logged and auditable
✓Zero auto-saves without human approval
✓Bias monitoring across all AI outputs
Compliance & Standards

SKCore Compliances — Standards & Frameworks We Design To

NABH 5th EditionNABL ISO 15189CDSCO SaMD IT Rules 2023DPDP Act 2023QOPI ASCO MeasuresNCG GuidelinesICMR Ethics
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See SKCore Compliances in Action

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