Korea · KGMP Gap Assessment
Bridging ISO 13485 to Bulletproof MFDS KGMP Compliance
Diagnose the 7 critical disparities between ISO 13485 and Korean KGMP rules prior to inspection to avert audit non-conformities.
Domain Expertise
Deep regulatory authority across every medical device domain
SaMD · AI Digital Health
IEC 62304 · Software Lifecycle · MFDS AI/Big Data & DTx Guidance
Pre-audit mock inspection remediated gamma sterilization gaps, resulting in zero major findings.
Active Devices · Robotics
IEC 60601-1 / 60601-1-2 (Ed. 4.1) · IEC 60601-2-XX Particular Standards
Essential Performance definition and worst-case test matrix optimization across accredited laboratories
Implants · Biomaterials
ISO 10993-1 to 23 Biocompatibility · ISO 11135 / 11137 Sterilization Validation
Biological endpoint matrix design and ISO 10993-18 chemical characterization / toxicological assessment
In Vitro Diagnostics (IVD)
Korea IVD Act & EU IVDR (2017/746) · CLSI EP Guidelines (EP05, EP06, EP12, EP17)
CLSI-compliant Limit of Detection (LoD), cross-reactivity, interference, and lot-to-lot reproducibility protocols
Proprietary Data & Precedent Validation
Clause-by-Clause Crosswalk & Empirical Audit Finding Analytics
100% Mapping Against MFDS KGMP Annex 2 & Top Inspection Findings
Engineered 4-Stage Workflow
A 4-Stage Pipeline from QMS Intake to Mock Audit & CAPA Closure
Locked Facility Scope & QMS Document Inventory
Incomplete baseline data or misclassified regulatory pathways are the primary drivers of multi-month submission delays. Gate 01 locks the device scope, predicate/standard mapping, and full document inventory before authoring begins.
Verification Baseline
Device description, intended use, existing test reports, and QMS document index
Gate Sign-Off Output
Confirmed classification matrix and locked submission master inventory
Agentic Automation & Platform Integration
Continuous Audit Readiness Powered by Leanabl eQMS
Clause-to-Evidence Instant Retrieval
Map every KGMP clause directly to verified SOPs, validation protocols, and sample DHR packets.
@Audit Management— Run "Clause-to-Evidence Instant Retrieval" across our KGMP Gap Assessment records and call out the highest-priority compliance findings first.
I'll inspect the linked quality and dossier records against target regulatory standards, then report actionable findings with verified outputs.
Thought for 4.2s · Explored Audit Management records & 14 regulatory clauses
Map every KGMP clause directly to verified SOPs, validation protocols, and sample DHR packets. Audit planning with finding and CAPA linkage
Automated Pre-Audit CAPA Tracking
Convert mock audit observations into tracked CAPA workflows with root-cause verification before the auditor arrives.
@CAPA— Run "Automated Pre-Audit CAPA Tracking" across our KGMP Gap Assessment records and call out the highest-priority compliance findings first.
I'll inspect the linked quality and dossier records against target regulatory standards, then report actionable findings with verified outputs.
Thought for 4.3s · Explored CAPA records & 14 regulatory clauses
Manage Korea regulatory annexes and document revisions with Part 11-grade electronic signatures and audit trails. CAPA workflow with bi-directional linkage
Service Specification
Service Scope & Final Deliverables
Scope
Comprehensive evaluation of quality manuals, site procedures, and batch records against statutory KGMP criteria.
- KGMP mandatory SOP, work instruction, and controlled form coverage
- Batch traceability, design & process change controls, deviations, and CAPA systems
- Facility qualification (DQ/IQ/OQ/PQ) and software/sterilization validation review
- Supplier evaluation, incoming inspection, and release testing documentation
- Reviewer-perspective non-conformity severity grading (Critical / Major / Minor)
Deliverables
Actionable documentation and remediation roadmaps to secure zero major non-conformities during on-site inspection.
- KGMP Clause-by-Clause Gap Matrix with severity classifications
- Missing & Deficient SOP Remediation Action List
- Validation Master Gap & Qualification Action Plan
- Inspector Defense & Audit Readiness Guidebook
- Pre-Audit Remediation Timeline & Milestone Schedule
| Category | Item / Milestone | Specification & Deliverable |
|---|---|---|
| Scope | Scope 1 | KGMP mandatory SOP, work instruction, and controlled form coverage |
| Scope | Scope 2 | Batch traceability, design & process change controls, deviations, and CAPA systems |
| Scope | Scope 3 | Facility qualification (DQ/IQ/OQ/PQ) and software/sterilization validation review |
| Scope | Scope 4 | Supplier evaluation, incoming inspection, and release testing documentation |
| Scope | Scope 5 | Reviewer-perspective non-conformity severity grading (Critical / Major / Minor) |
| Workflow | Stage 1: QMS Baseline Intake | Systematic receipt of quality manual, core SOPs, forms, and representative execution records. |
| Workflow | Stage 2: Clause-by-Clause Compliance Mapping | Direct mapping against MFDS KGMP standards to uncover omitted procedures and compliance deltas. |
| Workflow | Stage 3: Records & Validation Verification | In-depth audit of cleanroom controls, equipment qualification, CAPA files, and test records. |
| Workflow | Stage 4: Audit Readiness Report & Briefing | Delivery of prioritized deficiency matrix, remediation SOP guides, and audit rehearsal debrief. |
| Deliverables | Deliverable 1 | KGMP Clause-by-Clause Gap Matrix with severity classifications |
| Deliverables | Deliverable 2 | Missing & Deficient SOP Remediation Action List |
| Deliverables | Deliverable 3 | Validation Master Gap & Qualification Action Plan |
| Deliverables | Deliverable 4 | Inspector Defense & Audit Readiness Guidebook |
| Deliverables | Deliverable 5 | Pre-Audit Remediation Timeline & Milestone Schedule |
Frequently Asked Questions
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Built on our proprietary MFDS review database, our next-generation regulatory system compresses turnaround times to 1/5 and systematically prevents recurring deficiency cycles.