In the pharmaceutical industry, disaster recovery is not just about protecting business continuity; it is about safeguarding patient safety, data integrity, and the entire supply chain. The increasing complexity of global pharmaceutical operations exposes companies to a broad spectrum of risks, ranging from man-made disasters such as geopolitical conflicts to natural disasters that can cripple...
In today’s rapidly evolving pharmaceutical landscape, advancing technologies, shifting regulatory landscapes, and emerging global challenges such as supply chain disruptions, and drug shortages have significantly impacted how we develop, manufacture, and deliver treatments. These factors underscore the critical need for robust validation approaches for computerized systems to safeguard patient...
In the pharmaceutical industry, ensuring the safety, quality, and efficacy of products is paramount. With the increasing complexity of manufacturing processes, the growing reliance on computerized systems and advancements in technology, GAMP® guidance provides a framework for validating and maintaining the integrity of computerized systems, ensuring they are fit for their intended...
The landscape of clinical trials has been transformed in a post-pandemic world. In July, ISPE released the second edition of ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice. It addresses managing complexities associated with decentralized clinical trials, the benefits and challenges of using open-source software, and...
The ISPE GAMP® 5 Guide (Second Edition) was published on 29 July 2022. It was presented and discussed at the 2023 ISPE Europe Annual Conference, the 2023 ISPE Annual Meeting & Expo, and at several local...
