Change Notification

Viewing related articles

Stakeholder mapping tools

Stakeholder mapping tools

Workflows around change notification can become complex and involve diverse stakeholders from multiple organizations.  Consider a change that arises from a component manufacturer and is being notified by an integrator as shown in figure 1.     This simple case assumes that there is no request for additional information from the biomanufacturer and that the component manufacturer can simply accept any requests for last time buys before...

read more
Industry Scorecard

Industry Scorecard

In order to secure implementation it is important to be able to measure the current status and demonstrate success through timely progression towards a desired state. Demonstrating quick wins is essential to securing organizational support for ongoing efforts. This is especially true when attempting to have multiple companies align on a standardized industry way of working. The team has identified four areas critical to the success of change...

read more
Communications letter templates

Communications letter templates

One of the key aspects identified as part of the proposal for change notification best practices is good, clear and timely communication. Each company must take responsibility for communication around individual changes following its own practices and policies. However, the team did agree that for the sake of clarity it would be good for each organization that has implemented key aspects of these best practices to communicate this to their...

read more
Single Use: change notification guide

Single Use: change notification guide

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...

read more