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Blog » Archive by category "quality management systems"

What Data Integrity Means to Device Manufacturers

August 28th, 2015 by Zuhdi Hussein

Data integrity is an ever-increasing concern in life sciences, with medical. [...] Read More

Posted in Quality Management Systems

Anticipating FDA Initiatives for Risk Management

May 6th, 2015 by James Francum

Regulatory bodies like the FDA enact initiatives on a routine basis. While. [...] Read More

Posted in Risk Management

Is It Time for Your Firm to Undergo an FDA Mock Audit?

January 19th, 2015 by Zuhdi Hussein

Among compliance tools, FDA mock audits are undeniably useful. By giving. [...] Read More

Posted in Quality Management Systems

What Happens After Your FDA Form 483 Response Submission?

November 26th, 2014 by Henry Macartney

So you've received an FDA Form 483, but you were prepared. You completed a. [...] Read More

Posted in Quality Management Systems

Understanding the Results of FDA Gap Analysis

October 14th, 2014 by Zuhdi Hussein

FDA gap analysis helps organizations quantify the differences between their. [...] Read More

Posted in SOPs

How Can Your Firm Use Quality Risk Management?

July 25th, 2014 by Henry Macartney

Regulatory compliance can be tricky, especially when it comes to your. [...] Read More

Posted in Quality Risk Management

What Makes a Quality Management System Effective?

July 11th, 2014 by Henry Macartney

Modern quality management systems are often called upon to help their users. [...] Read More

Posted in Quality Management Systems

Meeting Compliance Goals With Deviation Management And CAPA Systems

June 2nd, 2014 by Henry Macartney

Your firm will experience compliance failures from time to time. In the realm. [...] Read More

Posted in Quality Management Systems

Implementing Comprehensive Quality Systems For FDA Medical Device QSR And Other Regulations

May 12th, 2014 by Zuhdi Hussein

The FDA's Quality System Regulation shouldn't act as a hindrance to medical. [...] Read More

Posted in Quality System Regulation 21 CFR 820

How to Ensure Your Firm Meets FDA Compliance Guidelines

February 25th, 2014 by James Francum

FDA compliance is obviously a pertinent issue for many life sciences firms. In. [...] Read More

Posted in Quality Management Systems

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