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
February 4th, 2016 by Henry MacartneyThe Applicable Scope of FDA 21 CFR Compliance
September 9th, 2014 by Zuhdi HusseinRegulatory [...] Read More
How Can Your Firm Implement QSIT Principles?
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?
July 29th, 2014 by Zuhdi HusseinWhat Makes a Quality Management System Effective?
July 11th, 2014 by Henry MacartneyModern 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
Meeting Compliance Goals With Deviation Management And CAPA Systems
June 2nd, 2014 by Henry MacartneyYour 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
May 12th, 2014 by Zuhdi HusseinThe FDA’s Quality System Regulation [...] Read More
Using Software Validation Of IT Systems For FDA Compliance
April 16th, 2014 by Zuhdi HusseinCompanies 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