Applying MHRA compliance software: NHS Huddersfield case study

The Medicines & Healthcare Products Regulatory Agency (MHRA) oversees the quality and compliance of all medicines and medical devices produced in the UK.

That's great for patient safety. But it means a lot of work for life science organisations looking to hit and maintain the MHRA's impeccable standards. 

The quality team at Huddersfield Pharmacy Specials faced typical NHS difficulties of stretched time, excessive admin and disconnected manual processes.

In 2019 they adopted EQMS by Qualsys to achieve 3 goals:


1) Simplify MHRA compliance 

2) Unlock new business opportunities

3) Make life easier by eliminating manual processes and freeing up time for continuous improvement


We spoke to the Huddersfield team about the project. Watch the video or read the transcript below.





Qualsys: What does quality mean to the Huddersfield Pharmacy Specials team?


Andrew Myers, Quality Control Manager: Quality is integral to everything to do.

We have a patient at the end of the line for our products, so patient safety is right up there in everyone's actions and deeds every day.


Josh Wheeler-Gaunt, Quality Assurance TechnicianIf our product is going to treat a sick patient, it's very important that what we produce is produced to a high standard and a good quality.

So for us, the documentation of everything, ensuring that everything proceeds as expected, that non-conformities are recorded and acted upon, helps us ensure a high-quality product is delivered.


Qualsys: How did you manage quality before EQMS came along?


Andrew: Most of our quality processes are very paper-based, very manual. And that's quite labour-intensive and not very efficient. 


Rochelle Scargill, Administration OfficerWe had 3,698 documents at the last count.

EQMS will be a lot slicker and less manual, and we'll get things through a lot quicker than we currently do.


Read blog post: 'How to demonstrate your document compliance to the MHRA'



Qualsys: Why did you choose EQMS?


Lynn Mason, Scientist Training Programme: EQMS is a really good tool to control our documentation system better, and our training. It's going to help us in a lot of ways.

It'll reduce the time we're taking over all our documents: reviewing and issuing and training. 


Minesh Shah, Production PharmacistEverything nowadays is becoming electronic, rather than a manual paper-based system.

EQMS will make things smoother, it'll ensure efficiency, and enable us to continue making good quality products.


Document control software


JoshI think EQMS will give us a more time-effective tool to see:

What actions are there?

When were they meant to be completed?

And if they're not completed, we can follow up with the relevant people specifically and quickly, rather than using an Excel spreadsheet in our current system - which is more onerous and difficult to work with.


Issue Manager workflow


RochelleWe'll be able to be a lot more responsive with things like customer complaints, spotting issues, getting change controls through more quickly - things which can all delay manufacturing and cause things to happen which shouldn't happen.


Andrew: EQMS will give us visibility around things much better. We'll have better performance indicators and we'll be able to see where we are in terms of our quality system.

And it'll let us maintain our compliance much more easily than previously.

If we maintain compliance, we'll satisfy the MHRA's needs and maintain our licence. That then allows us to concentrate on any areas that might be slipping or where we have non-compliance. We can tidy those areas much quicker and more easily.

People need to embrace this change because it's for the good of the unit, for the good of their careers, for the good of the patient at the end of the day.

So the things we're doing now are good, and introducing EQMS is an additional thing that'll make compliance better - and therefore gives us more opportunity in terms of business because we're a compliant, safe operation.



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Hear more real Qualsys customers discuss the impact of EQMS in our case study library:


Electronic quality management project case studies



Topics: GxP Pharmaceutical Regulation, Case Studies, MHRA, Customer Success, Interviews

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