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Gap Analysis Framework

Status: STUB — This document will be fully developed during Sprint 3 (D.1: Critical Gap Closure).

Purpose​

Define the methodology for conducting compliance gap analyses across the three regulatory frameworks targeted by the BIO-QMS platform:

  1. FDA 21 CFR Part 11 — Electronic records and electronic signatures
  2. HIPAA — Health Insurance Portability and Accountability Act (Security Rule, Privacy Rule)
  3. SOC 2 — Trust Service Criteria (Security, Availability, Processing Integrity, Confidentiality)

Gap Analysis Methodology​

To be developed in D.1.

Phase 1: Regulatory Requirement Mapping​

Phase 2: Current State Assessment​

Phase 3: Gap Identification & Classification​

Phase 4: Remediation Prioritization​

Phase 5: Evidence Collection Framework​

Gap Severity Classification​

SeverityDefinitionRemediation Timeline
CriticalBlocking regulatory complianceImmediate (Sprint 3)
HighSignificant compliance riskSprint 4
MediumBest practice gapSprint 5-6
LowEnhancement opportunityBacklog
  • docs/compliance/20-regulatory-compliance-matrix.md — Regulatory requirements mapping
  • docs/operations/64-security-architecture.md — Security controls baseline
  • docs/architecture/17-e-signature-architecture.md — E-signature architecture
  • prompts/58-gap-closure-prompts.md — AI-assisted gap analysis prompts