Software Quality Assurance (SQA) � GxP / CSV

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.

Responsibilities "No release without validated evidence and approved SLC compliance.”

SLC & Validation Governance

• Ensure mandatory SLC documentation is created, reviewed, and approved.
• Act as the final quality gate before deployment.
• CSV Oversight:
• Ensure end to end traceability (requirements → code → test → evidence).
• Oversee deviations, impact assessments, and CAPA.
• Confirm release readiness and validation completion

Quality Reviews & Compliance Assurance:

• Verify adherence to client SLC, customer SOPs, and quality standards.
• Proactively escalate quality, compliance, and regulatory risks.
• Delivery Enablement:
• Guide teams on right-sized documentation (avoid over/under validation).
• 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:

• Provide visibility on quality health, risks, and trends.
• 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.