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)!