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Software Quality Assurance (SQA) GxP / CSV Programs
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Role Purpose
The SQA is the quality authority for regulated software initiatives, ensuring that all changes, releases, and deployments comply with Client System Life Cycle (SLC) requirements, Computer System Validation (CSV) expectations, and global regulatory standards (e.g., 21 CFR Part 11, GAMP5).
The role balances compliance, delivery enablement, and risk-based decision-making, enabling predictable and audit ready releases.
________________________________________
Primary Accountability
No release without validated evidence and approved SLC compliance.
________________________________________
Responsibility
Act as the final quality gate before deployment
________________________________________
Oversee deviations, impact assessments, and CAPA
Confirm release readiness and validation completion
________________________________________
Proactively escalate quality, compliance, and regulatory risks
________________________________________
Validate documentation effort estimates and validation planning
Partner with delivery to enable compliance without execution delays
Ensure validation readiness ahead of major releases and go lives
________________________________________
Ensure continuity through strong documentation and knowledge transfer
________________________________________
Decision Authority
Block releases due to compliance or validation gaps
Accept or challenge risk justifications
________________________________________
Key Success Measures
Zero critical audit/review observations attributable to SQA gaps
On time releases with approved SLC & validation artifacts
High first-time right documentation quality
Early identification and mitigation of compliance risks
Software Quality Assurance (SQA) GxP / CSV Programs
________________________________________
Role Purpose
The SQA is the quality authority for regulated software initiatives, ensuring that all changes, releases, and deployments comply with Client System Life Cycle (SLC) requirements, Computer System Validation (CSV) expectations, and global regulatory standards (e.g., 21 CFR Part 11, GAMP5).
The role balances compliance, delivery enablement, and risk-based decision-making, enabling predictable and audit ready releases.
________________________________________
Primary Accountability
No release without validated evidence and approved SLC compliance.
________________________________________
Responsibility
- SLC & Validation Governance
Act as the final quality gate before deployment
________________________________________
- CSV Oversight
Oversee deviations, impact assessments, and CAPA
Confirm release readiness and validation completion
________________________________________
- Quality Reviews & Compliance Assurance
Proactively escalate quality, compliance, and regulatory risks
________________________________________
- Delivery Enablement
Validate documentation effort estimates and validation planning
Partner with delivery to enable compliance without execution delays
Ensure validation readiness ahead of major releases and go lives
________________________________________
- Stakeholder & Audit Interface
Ensure continuity through strong documentation and knowledge transfer
________________________________________
Decision Authority
Block releases due to compliance or validation gaps
Accept or challenge risk justifications
________________________________________
Key Success Measures
Zero critical audit/review observations attributable to SQA gaps
On time releases with approved SLC & validation artifacts
High first-time right documentation quality
Early identification and mitigation of compliance risks