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General IRA Checklist For Software

The document outlines a general checklist for conducting an initial risk assessment of GxP software applications, covering key areas such as system identification, intended use, business process linkage, GxP impact, and regulatory applicability. It emphasizes the importance of evaluating system complexity, criticality, data integrity, and validation planning to ensure compliance and mitigate risks. The final sections focus on risk determination and the necessary steps for approval and validation activities based on the assessment outcomes.

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Prasanna
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68 views3 pages

General IRA Checklist For Software

The document outlines a general checklist for conducting an initial risk assessment of GxP software applications, covering key areas such as system identification, intended use, business process linkage, GxP impact, and regulatory applicability. It emphasizes the importance of evaluating system complexity, criticality, data integrity, and validation planning to ensure compliance and mitigate risks. The final sections focus on risk determination and the necessary steps for approval and validation activities based on the assessment outcomes.

Uploaded by

Prasanna
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

General Checklist for Initial Risk

Assessment of GxP Software


Applications
1. System Identification
 System Name and Version
 Type of System (e.g., COTS, Customized, Bespoke)
 Developed by (Internal/External Vendor)
 Deployment Architecture (Client-Server, Web-based, Cloud, etc.)
 Technology Stack (Database, OS, Development Language)
 Environments Available (Development, Test, Validation, Production)

2. Intended Use & Functional Overview


 Purpose of the System
 Key Functional Modules and Operations
 Regulated Process Support (GxP-relevant activity)
 System's Role in Product Lifecycle (Direct or Indirect Impact)

3. Business Process Linkage


 Identify Relevant Business Processes
 Evaluate Integration Points with Other Systems
 Assess System’s Influence on Batch Release, Product Quality, or Compliance

4. GxP Impact Assessment


 Does the system support GxP processes?
 Does it store or process GMP-critical data?
 Are records required for batch release or audits?
 Does the system use electronic signatures or require audit trails?
 Is the system involved in decision-making impacting product safety or efficacy?

5. Regulatory Applicability
 21 CFR Part 11 (Electronic Records and Signatures)
 EU Annex 11 (Computerized Systems)
 MHRA GxP Data Integrity Guidance
 WHO TRS Guidelines
 PIC/S PI-011 Guidelines
 ICH Q9 (Quality Risk Management)
 GAMP 5 (Validation of Automated Systems)

6. System Classification (GAMP 5)


 Development Type (COTS, Configured, Bespoke)
 Software Category (GAMP Category 3, 4, 5)
 System Function (Infrastructure, Data Processing, Control System)

7. System Complexity Assessment


 Architecture Complexity (Single-tier, Multi-tier)
 Functional Logic and Workflow Rules
 User Roles and Access Rights
 Integration with Other Systems
 Data Flow and Business Logic Implementation

8. System Criticality Assessment


 Impact on Patient Safety
 Impact on Product Quality
 Impact on Regulatory Compliance
 Criticality of Data Managed by the System
 System Downtime Consequences

9. Data Integrity (ALCOA+) Considerations


 Attributable – User Access Control & Logging
 Legible – Human-readable Data Presentation
 Contemporaneous – Real-time Logging
 Original – Source Data Availability
 Accurate – Input Validation and Output Verification
 Complete – Audit Trails and Data Sets
 Consistent – SOP Compliance and Uniform Use
 Enduring – Backup and Archival Measures
 Available – Controlled Access and Retrieval

10. Validation Planning


 User Requirements Specification (URS)
 Functional and Design Specifications (FS/DS)
 Installation Qualification (IQ)
 Operational Qualification (OQ)
 Performance Qualification (PQ)
 User Acceptance Testing (UAT)
 Traceability Matrix (TM)
 Validation Summary Report (VSR)
 SOP Development & Training
 Backup and Restore Procedures
 Periodic Review Planning

11. Risk Determination Summary


 GxP Impact: Yes/No
 Regulatory Scope: Local/Global
 System Criticality: Low/Medium/High
 System Complexity: Low/Medium/High
 Validation Scope: Full Lifecycle/Partial

12. Approval and Next Steps


 Initiate or Plan Validation Activities Based on Risk Assessment
 Document Controls and Safeguards to Mitigate Risks
 Ensure Periodic Review and Change Control Alignment

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