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What Role Will Supplier Audits Play in Your Supply Chain’s Integrity?

December 2nd, 2014 by

Supplier AuditsWhere’s the weakest link in your compliance mechanism? While you may be well aware of the most problematic areas in the facilities you’re personally responsible for, supply chain compliance deficiencies have a way of sneaking up on [...] Read More

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

Demystifying FDA Corrective and Preventive Actions

February 6th, 2014 by

Corrective and Preventive ActionsRegulations outlined in FDA CFR 21 state that manufacturers must implement and maintain processes for corrective and preventive actions. Also known as CAPA systems, the implementations that deal with such actions take many forms, but they’re of the utmost importance for maintaining compliance not only in the United States, but the European Union as well.

What Does CAPA Do?

CAPA [...] Read More