Examples of Internal QMS Corporate Functions Audits we conduct:
Deviation and CAPA Management | Computer System Validation |
Documents and Change Control | Supplier Management |
Complaint Management | Inspection and Testing |
Professional Development & Training | Facilities and Equipment |
Medical Device Servicing | Technology Transfer |
Design Controls (Device) | Safety & Pharmacovigilance |
Device Master Records (Device) | Risk Management |
Device History Records (Device) | Auditing & Self-Assessment |
Management Reviews | Recalls & Field Action Mgmt. |
Warehousing / Storage | Packaging & Label Controls |
Stability Program (Pharma) | Shipping and Distribution |
The Quality of our auditing services are best in class meaning we provide more benefits and value-added services for less money!
We provide high-caliber, FDA Compliance Specialists with 15+ years of regulated industry auditing experience; we provide a cost-effective, fixed price audit for each audit we support; our fixed price audit includes: pre-audit preparation; audit planning; travel time (U.S. only); the audit itself; daily audit debriefs; the final audit report with one review cycle; and we assign a dedicated U.S. based audit administrator for every audit we support. Outsource our highly experienced auditors today!
FREE FDA Compliance Training $10,000 Value!
For each new Pharmaceutical, Medical Device, Biotechnology, and Healthcare Supplier client - After we support three (3) audits on your behalf, we will provide our most popular "21 CFR Part 11 & FDA Auditing of Computerized Systems" online training class for up to 5 employees for FREE ($10,000 value)!