GxP Compliance & Data Integrity

We have extensive experience with comprehensive testing and formal validation of information technology systems in a regulated environment in compliance with guidelines such as GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, MHRA, EMEA, HIPAA, and SOX including validation plans, protocol development, UAT, IQ/OQ/PQ, and traceability matrices.

CSV (Computer System Validation) - traditional approach

CSA (Computer Software Assurance) - new guidance from FDA. A risk-based approach for establishing and maintaining confidence that software is fit for its intended use. Least-burdensome approach for testing and documentation, commensurate with risk.

Risk-based testing includes:

• leveraging vendor/supplier testing

• unscripted testing

• limited scripted testing

• robust scripted testing

Data Integrity (ALCOA++)

With the growing emergence of AI, it is vital to sharpen focus on data quality and data integrity, building on fundamentals to further enhance enterprise data quality and increase data integrity, both being absolutely essential to improving AI capabilities and maximizing the leverage it can provide.

Audit Preparation & Inspection Readiness