Comprehensive Audit Services

AuditingLab provides end-to-end clinical quality assurance services for biotech, pharma, CROs, and clinical site networks. Our services are designed to keep you inspection-ready at every stage of development.

GCP Audit Support

• Site qualification and routine monitoring audits
• Vendor and CRO audits
• Internal system audits
• CAPA tracking and closure verification

GMP Audit Services

• Facility audits (IMP, CMO, CDMO)
• Batch record review
• Data integrity assessments
• 21 CFR Parts 210/211 compliance

GLP Audit Services

• Preclinical compliance audits
• QA unit effectiveness reviews
• Raw data integrity checks
• FDA/OECD requirements alignment

Inspection Readiness

• Mock FDA and EMA inspections
• Document control setup
• Staff inspection coaching

SOP & CAPA Operations

• SOP design, version control, and gap analysis
• CAPA root cause analysis and effectiveness verification
• Process mapping and workflow optimization

QA Training

• GCP refresher workshops
• Competency assessments
• Role-specific regulatory training

Our Process

1. Discovery: Understanding your current state and regulatory obligations.
2. Assessment: Gap analysis against applicable standards.
3. Custom Plan: Prioritized roadmap tailored to your program.
4. Implementation: Hands-on support through execution and closure.

Contact us to discuss your QA needs, explore our solutions, view pricing, or schedule a consultation. See what clients say in our testimonials, or browse our FAQ and open careers.