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
- Pre-submission document audits for INDs, Protocols, Consents, CRFs, Investigator Brochures, Final Study Reports, NDAs, BLAs, PMAs and MAAs and computer assisted applications
- CRO pre-and post-selection assessments
- Routine and For Cause Clinical Investigator Site Audits
- Inspection Readiness Assessments
- Clinical Database Audits
- Ethics Committee (IRB) Inspections
- Inspections of Specialized Contract Facilities
- Represent/Assist Corporations with Due Diligence Inspections
- Assist Corporations with FDA and EMEA Inspections
- Compliance Audit Database Development
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
- QA Unit GLP assessments and audits
- GLP protocol reviews
- Toxicology Laboratory Systems Audits
- PK/PD, ADME laboratory and data evaluations
- Laboratory pre- and post-selection assessments
- Clinical Laboratory test performance investigations
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
- Vendor/supplier qualification inspections
- Manufacturing Facility Inspections
- Manufacturing Process Validation Inspections
- Post Marketing Drug Safety Surveillance Inspections
- Inspections of Specialized Contract Facilities
- Comprehensive batch record review
- CMC documentation audits
Computer Validation: These audits are performed according to Title 21 Part 11, ICH Guidelines E9
- Electronic Data Capture Vendor Audits
- Interactive Voice Recognition Systems (IVRS) audits
- Comprehensive software development life-cycle documentation review