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Improving CAPA in the Regulated Industries

May 29th, 2014 by

CAPA SystemCorrective and preventive actions, or CAPAs, play a vital role in how GxP firms maintain compliance with FDA standards. A corrective action (CA) is an action to eliminate the cause of a detected nonconformity, or any other situation deemed to have adverse effects on a drug product. A preventive action (PA) is an action to eliminate the [...] Read More

How Does ISO 13485 Affect Your Company’s Ability to Do Business?

February 13th, 2014 by

ISO 13485 ComplianceAlthough medical device manufacturers have to adhere to a number of pertinent regulations to access foreign markets, there are some that stand out amongst the others. ISO 13485 is one such standard, and many firms strive to attain compliance with it.

Why ISO 13485?

For many medical [...] Read More