Every process within a laboratory is producing some type of data. The presented challenges range from vendors servicing a company's equipment holding themselves outside of the company's quality system, to not assuring that the data is true, accurate, concise, complete, and accurate in its entirety when it comes to laboratory data Integrity. Today's FDA regulations scope the electronic data as the true copy of data as opposed to 30 years ago when the hardcopy was the standard. Mitchell Wheeler, senior quality consultant at PharmEng Technology discusses the challenges the industry faces in data integrity compliance and avoiding audit violations.

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