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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

Executive Summary In the tightly regulated sectors of pharmaceuticals, biotechnology, and medical devices, strict adherence to Good Practice (GxP) standards is paramount. Selecting proficient auditors or auditing agencies is pivotal for ensuring GxP compliance across diverse supplier landscapes and environments. This whitepaper offers invaluable insights and practical tips for selecting the right partner to outsource

Introduction The pharmaceutical industry hinges on precision and safety. From drug discovery to manufacturing, every step must be meticulously controlled and documented. Computer systems are integral to this process, but how can their reliability be ensured? This is where Computer System Validation (CSV) comes into play. As technology has advanced, so has CSV, adapting to

Artificial intelligence (AI) has come to be a disruptive force in many different sectors

The pharmaceutical industry has long relied on Computer System Validation (CSV)

The first step in a successful audit is to clearly define its scope and objectives.

The integration of “Bots” into the workforce is rapidly approaching within the realm of Computer System Validation (CSV).

The U.S. Food and Drug Administration’s (FDA) and European Union’s…