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A regulatory audit is one of the most high-stakes events in the life sciences industry. Audit readiness in life sciences isn’t just about passing inspections, it’s about ensuring product safety, quality, and your company’s market position. For prepared companies, regulatory inspections bring a sense of quiet confidence, while unprepared organizations face observations, warning letters, or

Quality assurance and compliance are inseparable partners in today’s manufacturing landscape. When organizations separate these critical functions, they risk facing hefty fines, production shutdowns, and significant reputational damage. In fact, non-compliance with regulations not only leads to legal penalties but can also endanger public safety. We understand that implementing quality assurance best practices without proper

End-to-end test management has become crucial for ensuring software quality in today’s complex development environments. Did you know that end-to-end testing has been widely adopted because it helps teams expand their test coverage by adding more detailed test cases than other testing methods like unit and integration testing? This comprehensive approach to quality assurance is

A Validation Lifecycle Management System (VLMS) is an advanced framework or software platform designed to manage the entire lifecycle of your pharma or life sciences validation or qualification processes. It is particularly important for validating biotech products, medical devices, and other regulated industries. A VLMS ensures that your critical systems—including equipment and processes—are compliant with

In the pharmaceutical industry, maintaining product quality is critical to ensuring patient safety and efficacy. A Quality Management System (QMS) is fundamental to achieving these objectives, but as regulatory requirements evolve, the need for a Risk-Based Approach (RBA) becomes essential and this approach helps identify, assess, and mitigate risks to ensure product quality and patient

In the fast-paced world of pharmaceutical and life sciences industries, navigating the ever-evolving regulatory landscape can be daunting. Ensuring compliance while striving for operational excellence demands a sophisticated approach. Enter Veeva Vault QMS—a game-changing solution designed to not just meet but exceed modern compliance and efficiency standards. What Makes Veeva Vault QMS a Game-Changer? Veeva

As artificial intelligence (AI) continues to revolutionize the life sciences industry, companies are increasingly seeking solutions that can seamlessly integrate AI capabilities into their workflows. Understanding this trend, Veeva Systems recently announced its Veeva AI Partner Program, designed to support partners in the development of Generative AI (GenAI) solutions for Veeva Vault applications. This initiative

Introduction: Pharmacovigilance, a crucial aspect of the healthcare sector, plays a vital role in ensuring the safety and efficacy of medicinal products. It is a practice that has been in place for about 170 years in the medical industry.  Today this acts as a benchmark for all Pharmaceutical companies to live up to. The Good

In recent years, global supply chains have faced unprecedented challenges. The cGMP pharmaceutical industry has been no exception, experiencing significant disruptions due to the pandemic and geopolitical tensions. As we navigate these challenges, it is crucial to build a cGMP system that is not only stronger but also more resilient to future uncertainties. The Role

Introduction The pharmaceutical and life sciences industries rely heavily on computerised systems for several critical functions such as drug development, manufacturing, and quality control. Ensuring the integrity and reliability of these systems is a must for patient safety and data security. This is where Computer System Validation (CSV) comes into play. However, the growing cyber