21 CFR Part 11 Compliant Recipe and Batch Management - What’s Missing?

Overview:

In this paper (and associated presentation), the requirements to manage various levels of batch recipe within the pharmaceutical and other sectors within the Life Sciences sectors industry will be discussed, as well as the requirements to maintain secure batch records, including compliance with various electronic records and electronic signatures guidance. Examples of how this can be achieved within an ERP solution (without the need for a separate MES level batch or recipe management solution) will also be discussed.