Cross-Framework Mapping

ISO 22316vsICH Q10 - Pharmaceutical Quality System

See exactly how ISO 22316 controls map to ICH Q10 - Pharmaceutical Quality System. Pre-computed mappings, identified gaps, and coverage analysis.

1
Controls Mapped
32
Gaps Found
3%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 22316 maps to ICH Q10 - Pharmaceutical Quality System with 3% coverage across 1 directly mapped controls. Analysis of 33 ISO 22316 controls identifies 32 compliance gaps — primarily concentrated in ISO 22316: Business Impact Analysis.

Source: TheArtOfService Knowledge Graph | 33 controls analysed | 718 frameworks | 330K+ cross-framework mappings

Control Mappings

Showing 1 of 1 mapped controls across 1 domains. Sign up to explore all 330K+ mappings across 718 frameworks.

ISO 22316: Business Continuity Strategy(1 mappings)

ISO22316-14Supply chain continuity
ICH-Q10-Section2-Outsourced-Ownership-Vendor-Supplier-CMO-CROICH Q10 Section 2 - Outsourced Activities + Management of Materials + Change of Ownership + CMO + CRO + Supplier Management

Stop Paying Consultants to Read Spreadsheets

AI-powered compliance intelligence across 718 frameworks — at a fraction of consulting costs.

$0/forever

Free

  • 718 framework browser
  • Cross-framework mappings (330K+)
  • 824 compliance assessments
  • 3 AI queries & searches per day
Get Started Free
Recommended
$49/month

Professional

  • Unlimited AI Compliance Advisory
  • Unlimited full-text search
  • Framework self-assessment
  • PDF, Excel & CSV exports
Start 7-Day Free Trial →

What are the key differences between ISO 22316 and ICH Q10 - Pharmaceutical Quality System?

ISO 22316 has 33 controls across its framework, while ICH Q10 - Pharmaceutical Quality System covers 6 controls. Direct mapping analysis identifies 1 overlapping controls (3% coverage). The frameworks diverge most significantly in ISO 22316: Business Impact Analysis, where 5 ISO 22316 controls have no direct ICH Q10 - Pharmaceutical Quality System equivalent.

How many controls map between ISO 22316 and ICH Q10 - Pharmaceutical Quality System?

Of 33 total ISO 22316 controls, 1 map directly to ICH Q10 - Pharmaceutical Quality System controls — representing 3% coverage. The remaining 32 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO 22316 to ICH Q10 - Pharmaceutical Quality System?

32 ISO 22316 controls have no direct equivalent in ICH Q10 - Pharmaceutical Quality System. The highest concentration of gaps is in ISO 22316: Business Impact Analysis with 5 unmapped controls. These gaps represent areas where additional controls, policies, or documentation must be created to achieve compliance with both frameworks.

Which control domains have the most gaps between ISO 22316 and ICH Q10 - Pharmaceutical Quality System?

The domain with the highest gap count is ISO 22316: Business Impact Analysis (5 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.