What Data Integrity Means to Device Manufacturers

August 28th, 2015 by

Data SecurityData integrity is an ever-increasing concern in life sciences, with medical device manufacturers feeling much of the conformity backlash. There continues to be heightened regulatory focus on diverse cybersecurity topics, including data integrity.

Public and private sector organizations [...] Read More

Anticipating FDA Initiatives for Risk Management

May 6th, 2015 by

Guidelines Rules and ComplianceRegulatory bodies like the FDA enact initiatives on a routine basis. While their timing [...] Read More

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

January 19th, 2015 by

FDA Mock AuditAmong compliance tools, FDA mock audits are undeniably useful. By giving GxP-regulated organizations the chance to see how their operations would stack up against real-life inspectors, they make it easier to target and solve outstanding issues. [...] Read More

What Happens After Your FDA Form 483 Response Submission?

November 26th, 2014 by

FDA Warning Letter Form 483 ResponseSo you’ve received an FDA Form 483, but you were prepared. You completed a productive inspection close-out meeting and gained [...] Read More

Understanding the Results of FDA Gap Analysis

October 14th, 2014 by

FDA Gap AnalysisFDA gap analysis helps organizations quantify the differences between their real-world operations and the compliance rules that govern them. For instance, regulated firms commonly [...] Read More

How Can Your Firm Use Quality Risk Management?

July 25th, 2014 by

Quality Risk ManagementRegulatory compliance can be tricky, especially when it comes to your overarching quality management services. There are many guidelines, regulations and laws to understand in order to be compliant in [...] Read More

What Makes a Quality Management System Effective?

July 11th, 2014 by

Quality Management SystemModern 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 gap-analysis scheme to prepare your production lines for FDA and ISO audits and alike and simply plug in [...] Read More

Meeting Compliance Goals With Deviation Management And CAPA Systems

June 2nd, 2014 by

Deviation ManagementYour firm will experience compliance failures from time to time. In the realm of complex GxP-regulated processes, like automated pharmaceutical manufacturing and medical device quality assurance, things can go wrong with little advance warning.

While it would be nice to prevent such issues [...] Read More

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

May 12th, 2014 by

FDA QSR ComplianceThe FDA’s Quality System Regulation shouldn’t act as a hindrance to medical device manufacturers. While many companies are wary of falling afoul of the compliance guidelines contained in Title 21 CFR sections like Part 820, smart leaders realize that FDA QSR compliance can be a stepping [...] Read More

How to Ensure Your Firm Meets FDA Compliance Guidelines

February 25th, 2014 by

Pharmaceutical Manufacturing InspectionFDA compliance is obviously a pertinent issue for many life sciences [...] Read More