Compliance Group is excited to participate in MedTech Innovation & Validation University 2026, co-located with GMP University, bringing together life sciences professionals to explore the evolving ...
Compliance Group Inc. is excited to participate in the 2026 ISPE Annual Meeting & Expo, bringing together industry professionals to explore emerging technologies, regulatory developments, quality ...
Organizations spend approximately $2 trillion a year on digital transformation. Transformation efforts can yield up to 300% return on investment, yet it’s estimated that only 57% of organizations see ...
What is the difference between Computer Software Assurance (CSA) and Computer System Validation (CSV)? Is the FDA’s CSA guidance final, and does it apply to my organization? What is CLAiRE and how ...
What is the difference between AI-based compliance and traditional FDA audits?
The regulatory environment for manufacturers of medical devices in the United States is about to change in a significant way. The implementation of the FDA QMSR final rule has led to the modernization ...
On April 2, 2026, the FDA issued a warning letter that should be on the desk of every Quality leader in life sciences. It cites several familiar deviations — but embedded in the findings is something ...
In the highly regulated pharmaceutical industry, Project Management Office (PMO) governance ensures that projects align with compliance requirements and organizational goals. Given the FDA’s stringent ...
When a company is issued an FDA 482 Notice of Inspection and FDA 483 Warning Letter, it must prepare and be ready for the long adventure it will have to take with the FDA. Receiving an FDA 482 means ...
The Sarbanes-Oxley Act (SOX) is a U.S. law that was passed in 2002 to protect investors by preventing fraudulent accounting and financial practices at publicly traded companies. The law’s purpose is ...
Laboratory University contains 3 amazing events at one location! Each event contains a packed agenda with multiple sub-tracks of current regulations, industry trends and key areas of interest. Create ...
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