Managing CLIA Compliance Costs: 6 Mistakes Every Laboratory…
Clinical testing laboratories that perform testing in the United States must comply with Clinical Laboratory Improvement Act (CLIA) requirements. Compliance…
ISO 17025: What it Means for You and Your Laboratory
For testing laboratories or laboratories that perform calibrations, certified compliance with ISO 17025 standards isn't always easy. While many labs…
Managing Change Control to Comply with FDA and EU Regulations
Change is inevitable. That is why the concept of change control is critical, especially for pharmaceutical companies in FDA and…
FDA Experts Offer Top Tips to Optimize Your eCTD Submission
For some companies accustomed to paper submissions, the new electronic format was a challenge. The eCTD format is a change…
Writing and Enforcing Your SOPs for GxP Compliance Success
The white paper summarizes the basic needs for SOPs and the subsequent benefits that SOPs provide. It also addresses the…
How Quality and Compliance Can Help Reduce the Cost and Time…
Quality, compliance, time, and cost are all critical concerns for life science companies conducting clinical trials. This white paper discusses…