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FMEA Methodology As It Relates To The FDA And Medical Devices 

June 6th, 2014 by

FMEA for Medical DevicesAlthough it was originally developed for high-risk military assessments, Failure Mode and Effects Analysis (FMEA) methodology has become essential for medical device manufacturers. Firms that want to market products intended for human use must provide some assurance that these [...] 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

Quality Management Steps of Risk Assessment

May 22nd, 2014 by

CAPA Risk ManagementQuality risk management implementation identifies and manages risks; under normal circumstances the risk-based approach to the validation of computerized systems should eliminate the risks to the system, or should at least reduce the risks to a tolerable level. (This tolerable level must naturally be [...] Read More

Can Medical Device Compliance Consulting Benefit You?

April 29th, 2014 by

Compliance ConsultingAs all medical device manufacturers know, life sciences firms are bound by GxP rules and recommendations. Firms that want to create and maintain marketable product lines must be willing to subject themselves to intense regulatory scrutiny. They also have to comply with a range of rules pertaining [...] Read More

Understanding The CAPA Process During FDA Medical Device Compliance Inspections

April 14th, 2014 by

CAPA InspectionIn order to go public in the USA with a medical device, developers must pass FDA medical device compliance audits / inspections. Equipment falls into one of three categories based upon 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