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AUDITING

 

Auditing is a requirement under FDA's QSR (Quality System Regulations) as well as ISO 9001/13485. Audits provide the input into management review and allow for continual improvement.

 

 

At some instances, the company's personnel are "too busy" to notice existing (and sometimes chronic) problems.

 

We will conduct your internal audits. Our audits are designed to provide solutions, not only to point out the problems. This includes Statistical Process Control, Sterilization Validation Protocol, Packaging Validation, and other.

 

 

 

 

Mansour Consulting LLC -  US FDA and European medical device regulatory consultants

Phone: 678-908-8180, Fax: 678-623-3765, info@mansourconsulting.com

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