Ranking and Filtering (RRF)?

RRF is a structured tool used to assess and classify computerized systems based on risk to product quality, data integrity, and patient safety. It helps answer:

• Does this system directly impact GxP activities?
• What is the level of control and automation?
• How likely is it to cause a regulatory breach or quality issue?

Once systems are ranked, validation resources can be allocated more efficiently — higher scrutiny for high-risk systems, and leaner controls for low-risk ones.

3. Risk Ranking Criteria in CSV

Here are common risk criteria used in pharma RRF models:

Criterion	Description	Scoring
GxP Impact	Does the system impact patient safety, product quality, or data integrity?	1 (None) – 5 (Critical)
Data Criticality	Are records governed by 21 CFR Part 11 or Annex 11?	1 (Non-GxP) – 5 (Electronic batch record, audit trails)
System Complexity	Does the system require custom code or configuration?	1 (COTS) – 5 (Heavily Customized)
Frequency of Use	How often is the system used in critical operations?	1 (Rare) – 5 (Continuous)

Each system’s total risk score determines its classification — High, Medium, or Low — and the corresponding validation requirements.

4. Example RRF Scoring Matrix

System	GxP Impact	Data Criticality	Complexity	Use Frequency	Total Score	Risk Level
LIMS	5	5	4	5	19	High
Document Management	3	4	2	3	12	Medium
Email Server	1	1	1	2	5	Low

Tools like Excel, TrackWise, or Veeva Vault can be used to automate scoring models and store audit-ready risk registers.

5. Linking RRF to Validation Strategy

Once a system is classified, validation activities are tailored accordingly:

Risk Level	Validation Approach	Documentation Required
High	Full CSV lifecycle: URS, RA, DQ, IQ, OQ, PQ, Test Scripts, Audit Trail Testing	Complete VMP references, protocol approvals, validation summary
Medium	Streamlined CSV: Risk Assessment, OQ/PQ, User Testing	Config change logs, protocol execution records
Low	No validation; document rationale for exclusion	Risk register with justification

6. Practical Steps to Implement RRF

1. Inventory: List all computerized systems in scope (GxP and non-GxP)
2. Scoring: Use consistent criteria across sites and projects
3. Review: QA, IT, and system owners jointly review and approve risk level
4. Document: Maintain a risk register signed-off by validation leads
5. Apply: Tailor validation protocols and test scripts based on classification

7. Tools and Templates

• CSV SOPs with RRF templates
• Validation planning tools and risk checklists
• Excel-based scoring sheets with dropdowns and auto-calculated RPNs
• Validation summary templates with integrated risk matrices

8. Common Mistakes to Avoid

• Scoring all systems as “High” to be safe — this defeats the purpose of RRF
• Not involving QA in scoring — may lead to audit findings
• Failing to update risk classification after change controls
• Using inconsistent scoring scales between departments

9. Inspector Expectations

During audits, inspectors may ask:

• Show how you classified this system as “low risk” — where’s the documentation?
• Why was the audit trail not tested? Was this justified via risk assessment?
• How often do you re-evaluate system criticality?

Ensure that RRF documentation is easily retrievable and signed off.

Conclusion

Risk Ranking and Filtering is a cornerstone of efficient and compliant Computer System Validation in modern pharmaceutical environments. It aligns your validation strategy with risk, reduces unnecessary documentation, and enhances focus on high-impact systems.

By implementing a structured, cross-functional RRF process and linking it to your CSV protocols and Validation Master Plan, you not only meet regulatory expectations but also build a sustainable quality culture.

References

• FDA General Principles of Software Validation
• ICH Q9: Quality Risk Management
• EMA GMP Annex 11
• ISPE GAMP 5 Guide