Our gap analysis services provide a systematic evaluation of your current quality systems against regulatory requirements (FDA 21 CFR, EU GMP, ICH guidelines). We identify gaps, assess risk levels, and develop prioritized remediation roadmaps to achieve full compliance.
Regulatory Assessment
- FDA 21 CFR Part 11
- EU GMP Annex 11
- ICH Q10 guidelines
Gap Identification
- Current state documentation
- Compliance scoring
- Risk prioritization
Remediation Roadmap
- Actionable remediation plans
- Timeline & resource planning
- Progress tracking
Compliance Reports
- Executive summaries
- Detailed findings reports
- Audit trail documentation