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How to Ensure Your Firm Meets FDA Compliance Guidelines

February 25th, 2014 by

Pharmaceutical Manufacturing InspectionFDA compliance is obviously a pertinent issue for many life sciences [...] Read More

What Goes Into Quality Assurance For Medical Devices

February 20th, 2014 by

Medical Device Quality AssuranceQuality assurance (QA) isn’t something implemented solely for consumer satisfaction. In most industries, including that of medical device manufacturing, your QA efforts have very real effects on your ability to legally conduct business in the United States, EU and other global locations.

In some cases, meeting quality management regulations may be more difficult using only in-house resources. Learn how [...] Read More

The Dangers of Relying Solely on General Guidelines to Perform Software Validation for FDA Compliance

February 18th, 2014 by

Software Validation ComplianceThe FDA has established, via the issuance of General Principles of Software Validation, far reaching and comprehensive validation requirements relating to all software utilized for “…design, [...] 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

Is Seeking Outside Consulting Advantageous In The Medical Device Industry?

February 11th, 2014 by

Supply Chain ManagementThe manufacture and sale of medical devices, be they intravenous catheters or operating tables, is a highly complex undertaking requiring a deft balancing of FDA regulatory concerns with ambitious output [...] 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

Why Is FDA 21 CFR Part 11 Compliance Important?

February 4th, 2014 by

Electronic RecordsComplying with Part 11 can be a difficult thing to do. This is in part due to the fact that FDA recalled all the guidances concerning the implement of Part 11 in September 2003. Companies have been left to their own means to interpret Part 11, since the FDA leaves the inspector’s interpretation to “his own discretion.”

Originally, the regulation was drafted and issued by the Agency at the request of the regulated industries. These industries [...] Read More