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Blog » Archive by category "fda compliance"

Key Characteristics of FDA Part 11 Compliance

February 4th, 2016 by Henry Macartney

Properly managing sensitive information to maintain privacy and security has. [...] Read More

Posted in FDA & European Regulations

The Applicable Scope of FDA 21 CFR Compliance

September 9th, 2014 by Zuhdi Hussein

Regulatory compliance is important for any life-sciences firm, but the breadth. [...] Read More

Posted in GxP CC

What Goes into CSV Compliance?  

September 5th, 2014 by Henry Macartney

Most of the more complex computer systems employed by life-sciences firms are. [...] Read More

Posted in GxP CC

How Can Your Firm Implement QSIT Principles?

August 25th, 2014 by Henry Macartney

Are You Using QSIT Principles? [...] Read More

Posted in Quality Systems Inspection Technique

Can Your Choice of Software Affect Your FDA Part 11 Compliance Efforts?

July 29th, 2014 by Zuhdi Hussein

FDA 21 CFR Part 11 isn't as broad as some regulations. Nonetheless, it's. [...] Read More

Posted in GxP CC

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

Medical Device Risk Management and ISO 14971

June 26th, 2014 by Zuhdi Hussein

ISO 14971 is one of the ISO standards that define the international. [...] Read More

Posted in medical device risk management

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

Using Software Validation Of IT Systems For FDA Compliance

April 16th, 2014 by Zuhdi Hussein

Companies which must work in a GxP environment rely on a range of different. [...] Read More

Posted in IT Systems Software Validation

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