Compliance Audits

Our auditors are selected based on their proven abilities, level and depth of experience in each of these areas and match the auditors with our client’s needs. A sampling of the types of compliance activities includes:

Systems Audits: Our systems/process audit approach is to tailor the audit plan to your particular needs. Audits are performed to the applicable standards and regulatory requirements. The goal is to better understand current systems, identify opportunities for systematic improvement, enhance inspection readiness, and provide management information critical to project advancement.

Good Clinical Practices Audits: Performed according to Title 21 CFR Parts 50, 54, 56, 312, 314, 316, 320, 812, 814, ICH Guidelines E2A, E2C, E3, E6, E9, M4, EU Clinical Trials Directive

Clinical and Non-Clinical Laboratory Audits: These audits are performed according to Title 21 CFR Parts 58, Title 42 Part 493, ICH Guidelines S2A, S3B, S4, S6

Good Manufacturing Practices Audits: These audits are performed according to Title 21 CFR Parts 210 to 290, 600 to 680, 820 to 822, ICH Guidelines E2B, E2D

Computer Validation: These audits are performed according to Title 21 Part 11, ICH Guidelines E9