The different processes involving multiple roles like supplier, production, manufacturer, and pieces of equipment for designing or marketing a product will inevitably invite some non-conformance ...

In the realm of computer software assurance (CSA), the landscape is evolving at warp speed. Traditional approaches, such as Computer Software Validation (CSV), are giving way to more agile and ...

In the realm of Computer System Validation (CSV), risk assessment stands as a cornerstone in ensuring the safety, efficacy, and compliance of software systems, particularly in regulated industries ...

As the FDA and other regulatory bodies raise the bar for software validation in healthcare and life sciences, computer software assurance (CSA) activities are becoming increasingly critical to ...

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 ...

What exactly is Compliance documentation and how do you know if you are creating clear, concise, accurate content? In the life sciences field compliance documentation is crucial for meeting regulatory ...

Managing complex projects starts with clear defining goals and aligns with Compliance strategic objectives and workforce planning. Clear understanding of the project requirements and challenges with ...

In the dynamic field of project management, achieving success and alignment with organizational goals is crucial. At the core of this endeavor is the Project Management Office (PMO), which plays a ...

PAT tools and technology solutions are continually evolving to become more user-friendly, advanced and reliable. These improvements are making it easier for organizations to adopt and integrate PAT ...

The journey of implementing and validating Veeva Quality Management System (QMS) in life science companies can be a transformative, sometimes challenging, and rewarding endeavor. As a Quality Manager, ...

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 ...