Advancing diagnostics, automating workflows, and enabling personalized medicine all depend on trust. In healthcare and life sciences, where patient safety, product quality, and data integrity are ...

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 highly-regulated life sciences industry, maintaining product quality and compliance is essential for patient safety and organizational success. One of the core elements in achieving this is the ...

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 ...

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 ...

Innovations and Emerging Technologies in the Regulated Environment of Pharma Effective training programs are essential for maintaining compliance, improving operational efficiency, and ensuring data ...

Navigating FDA 21 CFR Part 11 compliance requires a strategic approach to Computer System Validation (CSV)and Computer Software Assurance (CSA). Title 21 of the Code of Federal Regulations establishes ...

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 vision and methodologies of Process Analytical Technologies (PAT) closely align with emerging trends such as Industry 4.0 and Internet of Things (IoT). Although these trends have gained ...

In the rapidly evolving pharmaceutical and biotechnology industries, Veeva Vault stands out as a transformative platform for managing critical data and processes. At Compliance Group (CG), we ...

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 ...

ISO 13485:2016 is an international standard for medical device manufacturers and providers of quality management systems. ISO 13485:2016 is not a law or regulation and is voluntary, while FDA 21 CFR ...