We offer to companies that are regulated by the FDA and other agencies a complete range of testing and validation services within the life sciences arena, encompassing computer systems validation (CSV), testing of regulated and non-regulated systems, equipment and facilities qualification, and regulatory compliance (21 CFR Part 11, GxP, PDMA, Sarbanes-Oxley (SOX), etc.). Our skilled team has the necessary training in FDA and other industry regulations and best practices, such as risk-based methodologies to succeed in our client engagements.

We support our clients quality, compliance, and operational goals on engagements with the following activities: requirements definition and traceability; risk assessment and risk mitigation; validation planning; internal and external vendor audits; SOP development; test plan and test script creation and execution; validation summarization; deployment; and ongoing validation maintenance.

We can either take on a leadership role and manage the entire validation project following our quality program with scheduled deliverables and staffed with our consultants, or provide staff to join our clients' team at their site and following our client's quality program.