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 today's rapidly evolving technological landscape, industries such as life sciences, pharmaceuticals, and medical devices are increasingly challenged to maintain regulatory compliance while driving ...

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 ...

Organizations in today’s fast-paced, complex business environment turn to strategic consulting to gain a competitive edge, navigate transformation, and drive sustainable growth. While consultants ...

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 ...

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 ...

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, ...

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 ...

Join us at 2024 Medical Device Innovation Consortium (MDIC) Quality Summit, Where you will learn about adoptable cutting-edge practices to maximize the impact of investing in quality across your total ...