System Development & IT Compliance Audits

A well-defined System Development Life Cycle (SDLC) and robust IT compliance processes are essential for maintaining control over GxP-regulated systems. We provide expert guidance and independent assessments to help you establish, refine, or evaluate system development, validation, and IT quality programs.

• SDLC Program Development & Optimization – Establishing or improving system development, testing, and change management processes to align with regulatory expectations.

• IT & Compliance Audits – Conducting independent assessments of validation, qualification, and IT quality programs to identify gaps and recommend improvements.

• Open-Source Software Compliance Assessments – Evaluating the use and security of open-source components (e.g., data remains secure and within your organization) in regulated environments and defining appropriate verification and validation strategies.

• Vendor & Third-Party Compliance Audits – Assessing vendors, cloud providers, and IT service partners for compliance with GxP, Part 11, and Annex 11 requirements.

Our risk-based approach ensures that your SDLC and IT compliance processes are well-documented, controlled, and audit-ready, supporting both new system implementations and evaluating existing compliance frameworks.