Digital Transformation (DT) is impacting every aspect of our personal and professional lives, so it was no surprise that nearly one-third of all presentation proposals for this year’s ISPE Annual Meeting involved DT topics. It is a testament to the breadth of DT that there are three ISPE Communities of Practice (CoPs) operating in this space, each of whom had submitted high-quality...
It may seem that the only things loved by pharma industry more than acronyms are new buzz phrases. And that may be true. But sometimes, behind the buzz phrase, there are real, strong, achievable benefits to our work, our industry, and our end patients.
ISPE GAMP® has led the way in computerized systems best practices for more than 30 years. GAMP brought us the concept of system lifecycles and leveraged the V-model to give us a structured approach to computerized systems validation (CSV). GAMP developed and adopted the risk-based approach to CSV, enabling industry to focus validation efforts on critical systems and functionality.
Use of software as a service (SaaS) applications within the life sciences industry is growing. This article reviews the issues and challenges faced by SaaS providers and identifies the qualities of successful providers for this highly regulated industry.
