Transforming Pharma Development: Digitalization and QbD
Nowadays, integrating data and digital information, in general, has emerged as a topmost concern for numerous industries, and the Life Sciences sector is no exception. With these, the new challenges and opportunities emerging result in the necessity of continuous adaptation and innovation, particularly in the regulatory field.
The International Council for Harmonization (ICH) Quality guidelines comprise a collection of regulatory standards designed to harmonize requirements across regions for the quality of pharmaceutical products. These guidelines aim to safeguard the safety, efficacy, and quality of products throughout their lifecycle.1 In this article, we will focus our attention on different ICH guidelines that highlight concepts related to pharmaceutical development under Quality by Design (QbD) framework, risk management, pharmaceutical quality systems, development and manufacture of drug substances and lifecycle management.2–6 In this context, case studies demonstrating the application of these guidelines leveraging on digital platforms will be discussed.
About ValGenesis
ValGenesis is the pioneer of paperless validation, and the inventor of the ValGenesis VLMS, the industry’s first, proven, 100% paperless validation lifecycle management solution, trusted by hundreds of life science customers as a system of record for validation. Covering the entire lifecycle process, ValGenesis VLMS delivers technology solutions that are validated, fully configurable and rapidly deployable through a validated private secured Cloud. ValGenesis VLMS enables new levels of collaboration, data integrity, risk management, and compliance with validation lifecycle.
