Computer System Validation (CSV)

Validating and maintaining GxP-regulated IT systems requires a risk-based approach that aligns with industry best practices, GAMP guidelines, and regulatory requirements such as 21 CFR Part 11 and Annex 11. Whether you are implementing a new system, assessing an existing one, or transitioning to CSA principles, we provide the expertise and documentation needed to ensure compliance.

•  CSV/CSA Strategy Development – Defining the appropriate validation and assurance approach based on system risk and regulatory expectations.

• Validation Planning & Execution – Developing and implementing:

• Validation Plans, User & Functional Requirements (URS, FRS, DS), Risk-Based Testing (IQ/OQ/PQ), and Traceability Matrices.

• Cloud and SaaS System Validation, including QMS, LIMS, ERP, MES, and Document Management platforms.

• Qualification of custom software (i.e., GAMP Category 5).

• Qualification of Data Analytics platforms (i.e., Power BI reporting).

• Development of SharePoint Qualification and Security guidelines[BV1] .

• Data Integrity & Part 11/Annex 11 Compliance Reviews – Assessing electronic records, signatures, and audit trails to identify compliance gaps.

• Remediation & Continuous Compliance Support – Updating existing validation programs to reflect current regulatory expectations and industry trends.

We tailor our CSV/CSA services to fit your organization’s needs, whether you’re implementing validation controls for the first time or optimizing an established framework.