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Pharmaceutical Manufacturing and Packing Sourcer

Scaling the Compliance Mountain

As market dynamics are pushing companies to streamline processes and seek greater efficiencies, many are looking towards enterprise quality management software (EQMS) as a means of minimising overhead expenditure, providing instant access to accurate data, and delivering a controlled, standardised platform for identifying and resolving quality issues.

While it is easy to quantify the business benefits of EQMS, many organisations are put off by the perceived financial implications of realising such a system – namely a dent in production due to down-time and the costs of partnering with a specialist provider.

The Purple Guide
seeks to dispel some of these myths surrounding implementation, and acts as a step-bystep guide for those considering an emerging enterprise software model. Written in a conversational tone, the book is easy to read and accessible to all; the absence of sector-specific case studies means that the content is broad and applicable across a wide range of businesses, be they life sciences or something different.

With this in mind, the book successfully utilises the theme of a journey up the compliance mountain, with the end goal – successful execution and measurable value – representing the summit. Moving through the preparation, implementation and operation stages, the reader is taken from the base camp to the equipment shop, through the climb to the final ascent, and lastly above the compliance clouds. All the while, the novice is encouraged to think about how to prepare, what they should expect, and an established way of proceeding to get the most out of the time and budget they have available. Without offering a definitive answer, The Purple Guide provides the basis for further, individual exploration, and points out the questions a company must ask to find the solution that is right for them.

The value of external help is reiterated throughout the book, recommending collaboration with a good ‘mountain guide’ that will facilitate effective discussion, assess the current situation and desired goals, analyse the organisation in the context of an EQMS, and produce an action plan to ensure all aspects of the transition are properly considered. At the same time, businesses are reminded to strike the right balance between people, processes and technology to guarantee that the switch remains smooth. While it is easy for internal project leaders to get caught up with the implementation process itself, this should be the simplest stage of the journey if planned effectively.

And the journey does not stop following implementation. The book reminds companies that in order to ensure continued regulatory compliance and improvement, the system must be maintained in a way that is appropriate for the organisation and the sector. A number of categories of change are listed, along with their implications, prompting firms to fully ground their EQMS for years to come.

With a combination of diagrams and tables positioned alongside the text, The Purple Guide is an ideal tool for those considering or already embarking on EQMS compliance. With general information as well as advice on good practice, organisations should be left in a position where they feel more confident about making decisions based on their specific circumstances – rather than being caught up in a whirlwind of jargon and misconceptions. For a beginner to this field, the book should provide a valuable source of guidance on a system that is often over-complicated.

The Purple Guide is published by Formpipe.GxP. To register for a free copy, visit:
ISBN: 978-0-9932148-0-6

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