Audits

We specialize in audit services for internal application development and external application vendors, computerized systems, data services, data centers, SaaS and external vendor qualification to FDA 21 CFR Part 11, EU GMP Annex 11, and GxP (GCP/GLP/GMP) global regulations. We perform Qualification audits of PQ packages for end users OQ packages for application vendors, and IQ packages for data centers.

Other audit offerings include customized For Cause Audits and Follow-up Audits

We can be the Part 11 subject matter expert (SME) on your QA audit team or conduct independent audits. Our assessments follow known industry standards such as GxP regulations and guidance, IEEE software quality standards, ISO 9000 quality systems, and GAMP. Audit Report structure follows industry standard for software audit reports.

We are ready to help with “due diligence” audits of third party data centers, software developers, contract research organizations, SaaS applications, company GxP system validation projects of all sizes, quality management systems (QMS) for validation, and documentation packages for System IQ, Supplier OQ, and End User PQ. We look forward to discussing your needs.