Single Use: change notification guide

newsJun 19, 2017 | Change Notification | News

This guide is written by a combined BioPhorum/Bio-Process Systems Alliance (BPSA) team details how to notify changes effectively and reduce the time and effort spent on change notification. It is the reference document for an industry wide effort to implement better ways of working in this critical area. The objectives of this program are to enable inventory management improvements and reduce the negative impacts of single use changes on the supply chain This guide can be found on both the BioPhorum and BPSA websites.

 

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Single-use, change notification: Guidance and implementation tool kit
13.12 KB 4 file(s)
Release Date - 26th June 2018
Abstract
The biopharmaceutical industry is increasing dependant on the use of single use systems to enable manufacturing. These systems are often customized and built from many parts, from a range of component suppliers. Change notification and change management it this complex ecosystem is very difficult unless all suppliers, integrators and users follow the same system and standards for change notification. This guide provides a definition of best practices that once adopted across the ecosystem will deliver an effective and harmonized change notification system between companies. Specifically it provides an understanding that all companies should categorize changes,standardizes content of a pre-notification and a notification and provides a reporting template, and workflow

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