Quality & Compliance
Creating an Effective Global Audit Strategy for Medical Device and Diagnostic Companies: A Tale of Two Paths
The Crossroads of Global Compliance For medical device and diagnostic companies operating in today’s global marketplace, success depends on more than just innovative products — it hinges on a...
Regulatory Sciences
FDA Inspection Readiness: Top Observations and How to Avoid a Form 483
For medical device manufacturers, FDA inspections are a critical component of regulatory oversight and quality assurance. Whether part of a routine surveillance program, pre-approval inspection, or...
Quality & Compliance
Staying Ahead: Why BIMO Inspection Readiness Audits Are Essential for Clinical and Biological Research Compliance
In the world of clinical and biological research programs, ensuring compliance with regulatory standards is not only essential for maintaining the integrity of studies but also for safeguarding the...
Quality & Compliance
What You Need to Know About GxP Independent Compliance Audits, Part 2
Welcome to Part 2 of our blog series on "What You Need to Know About GxP Independent Compliance Audits." In Part 1, we discussed the importance of GxP audits, the different audit types, and why...
Quality & Compliance
Clinical Trial Good Clinical Practice (GCP) Audits – Are you ready?
Good clinical practice (GCP) is an international ethical analysis and scientific quality standard for designing, conducting, and auditing clinical trials that involve the participation of human...
Quality & Compliance
Your Vendor Audit Program: On-site or Remote / Virtual?
It is quite common that a sponsor company will outsource services to external vendors, whether for additional expertise, remote locations, or simply due to lack of availability of resources within...
Quality & Compliance
Top Tips for a Successful Virtual Audit
The COVID-19 pandemic forced countless companies to change the way they do business in order to continue operating while protecting employees and upholding their social responsibility to the...