Properly managing sensitive information to maintain privacy and security has become paramount in recent years. Today, [...] Read More
Key Characteristics of FDA Part 11 Compliance
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Regulatory [...] Read More
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August 25th, 2014 by Henry Macartney
Are You Using QSIT Principles?
Today’s medical device manufacturers must [...] Read More
Can Your Choice of Software Affect Your FDA Part 11 Compliance Efforts?
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[...] Read MoreWhat Makes a Quality Management System Effective?
July 11th, 2014 by Henry Macartney
Modern quality management systems are often called upon to help their users meet varied regulatory standards and guidelines. For instance, your company may employ a single [...] Read More
[...] Read MoreMeeting Compliance Goals With Deviation Management And CAPA Systems
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Your firm will experience compliance failures from time to time. In the realm of complex [...] Read More
Implementing Comprehensive Quality Systems For FDA Medical Device QSR And Other Regulations
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The FDA’s Quality System Regulation [...] Read More
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 technologies to maintain consistent quality and levels of output. In addition to the control software these organizations employ to manage their manufacturing and marketing operations, modern companies also [...] Read More