Plug-and-Play audit trail requirements

Plug-and-Play audit trail requirements

This document is one of a series, written to address the problems associated with automating equipment that lacks interoperability in the biopharmaceutical industry. It relates to the BioPhorum Stirred Tank Unit Interface Specification referenced in Appendix A, which...
Plug-and-play computerized systems validation strategy

Plug-and-play computerized systems validation strategy

The Plug-and-play computerized systems validation strategy is a guidance document aimed at maximizing the benefits of adopting the BioPhorum approach to interoperable, modular equipment assemblies (commonly referred to as ‘skids’). The approach is based on NAMUR´s...
Biomanufacturing technology roadmap:  4. Automated facility

Biomanufacturing technology roadmap: 4. Automated facility

This chapter of the First edition biomanufacturing technology roadmap published in 2017, describes the vision, scope and benefits that could be gained in the biopharmaceutical manufacturing industry from the development and implementation of effective automated...