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The EBR Implementation Guide: Introduction

So, You Want to Move from Paper –
​But How Can We Reduce the Complexity of Implementing EBR?
 
 
 
Introduction
​In the manufacturing industry evidence is piling up of the upsides possible from deploying Industry 4.0 type technologies. These digitisation projects are typically showing results more tightly aligned to individual companies’ objectives than we’re used to seeing with traditional more rigid systems. Largely thanks to their flexibility catering for many different ways of working, meaning a standard COTS system that can be configured to match companies’ specific needs and business processes rather than the other way round.


​For pharmaceutical manufacturing, digitisation has proven difficult and somewhat illusive. Quality obligations to patient’s and GMP regulators add significant complexity, resulting in a limited choice of suitable products, and typically slow, expensive projects with a heavy documentation burden compared to non-regulated industries.

These newer technologies have the capability to change this, and the prospect of more mass-market type software solutions finally being capable of supporting GMP use paints a tantalizing prospect for business leaders in the field, and is at the very foundation of the concept known as ‘Pharma 4.0’.
 
Pharma 4.0 & The Batch Record
At the heart of Pharma 4.0 (from a manufacturing perspective) sits software usually called Electronic Batch Record (EBR), this is because it handles the core functions of both quality assurance and production efficiency. EBR has typically been one of the toughest areas for manufacturers, largely due to the established software products (often bundled with an MES) eye-wateringly high cost, time to value, and efforts required to implement; the output of which often being a system so complex to use and maintain they are often never completely rolled-out.

This was precisely what we setup our cloud-based BatchLine product to solve, having painstakingly included many of these barriers as fundamental product requirements from the start.

By design the BatchLine product eliminates much of this just by how you set it up and use it, but there are many common EBR implementation pitfalls caused by the wrong approach or project management regardless of the tool.
 
Best Practices & Common Mistakes
So what else can speed and smooth the adoption of EBR into a running GxP facility? And do you have to implement a full EBR everywhere to get the benefits? These articles aim to help you benefit from BatchLine and Factorytalk’s years of successes (and failures) by sharing our learnings and techniques to help you run a smooth project, and create a path to a timely and successful go-live which delivers its objectives. We normally only share these in real projects with paying customers, but provide them here free of charge as part of our marketing. 

Check out ​other chapters

Read for our next articles in this serie in which we will provide more advice about implementing an Electronic Batch Recording system.

Part 1:

Tips on scoping the initial EBR deployment

Part 2:

Selecting a suitable EBR

Part 3:

POC's, POV's, Trials

Part 4:

Kick-off to Go-live with your 1st Product on EBR in 2 months

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