GxP

Figure 1: Key characteristics of the ISO/IEC 25010:2011 product quality model
Features
Quality Agreements for SaaS Solutions Intended for GxP Use

As adoption of cloud technology continues to increase across the life sciences industry, so too does the need to establish a standardized and pragmatic approach for ensuring the quality of software applications used in support of GxP data and associated processes. This article focuses on the application level and the growing use of software as a service (SaaS) within the life sciences...

Maturity model
Features
AI Maturity Model for GxP Application: A Foundation for AI Validation

Artificial intelligence (AI) has become one of the supporting pillars for digitalization in many areas of the business world. The pharmaceutical industry and its GxP-regulated areas also want to use AI in a beneficial way. Several pharmaceutical companies are currently running digital pilots, but only a small fraction follows a systematic approach for the digitalization of their operations

Video

GAMP® Good Practice Guide for GxP Compliant Lab Computerized Systems Webinar

This webinar will discuss the lifecycle of computerized laboratory equipment, with some discussion of the similarities and differences to computer system validation, and the use of quality risk management to right-size...