Information modelling for validation in GMP
Abstract
This paper briefly describes validation in Good Manufacturing Practice, and describes some of the problems with the current document-based approach. It suggests an alternative approach based on Information Modelling and emerging standards that define the meaning of information. Current work, on the eValid project, to define and implement the information requirements for validation is described and possible business benefits are outlined which will be enabled by successful use of these methods.
Fields of Study & Subjects
Quality and Management Systems
Business Process Modeling and Analysis
BIM and Construction Integration
Publication details
- Journal / source
- CRC Press eBooks
- Pages
- 903–908
- Publication date
- 11 February 2026
- Language
- EN
- Document type
- Book chapter