Data integrity is an ever-increasing concern in life sciences, with medical. [...] Read More
What Data Integrity Means to Device Manufacturers
August 28th, 2015 by Zuhdi HusseinPosted in Quality Management Systems
Anticipating FDA Initiatives for Risk Management
May 6th, 2015 by James FrancumRegulatory 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 HusseinAmong 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 MacartneySo 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 HusseinFDA 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 MacartneyRegulatory 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 MacartneyModern 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 MacartneyYour 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 HusseinThe 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 FrancumFDA compliance is obviously a pertinent issue for many life sciences firms. In. [...] Read More
Posted in Quality Management Systems
