Not being able to identify areas of risk regarding your system’s Computer Validation and Part 11 compliance efforts won’t allow you to uncover the compliance vulnerabilities that FDA inspectors
look for. 

Compliance professionals, within the pharmaceutical and medical device industries, employ audits to monitor their quality assurance processes in an effort to identify areas of risk for their procedures, documentation, controls and systems. Audits also provide advance warning of new enforcement targets.

And when you purchase software or computer systems from vendors, you are still the one
answering to FDA for their overall validation. Obtaining third-party audits of your vendors’
products is vital in assuring your supplier has approved standards in place.

Hundreds of pharmaceutical and medical device professionals have looked to QA Edge in
conducting their internal audits as well as third-party audits of their vendors. Our
unique approach places less emphasis on checklists and more on the “common sense”
approach – diverting currently wasted resources into more meaningful, value-added
activities.

Click here to learn the contents of a typical QA Edge audit.
Click here for an overview of QA Edge’s audit experience.

Contact us to uncover the vulnerabilities you may currently be overlooking.