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 Automated quality assurance

When making a living from providing regulatory specialist knowledge to the biotech, pharma and pharmaceutical industries, quality assurance in all procedures and processes must be under control. IWA Consulting is aware of that, which is a leading Danish consulting house within the provision of regulatory support to customers all over the world.

This also involves our own internal processes, says Johnny Hansen, Senior Director medical Device, who on a daily basis, among other things, is quality responsible at IWA Consulting.

Our requirement was rather a solution that far down the road could do the same thing - just smarter and more efficient. As we make a living by offering our knowledge and competencies to our customers, it is extremely important for us to constantly optimize the internal processes.

— Johnny Hansen, Senior Director, IWA Consulting

 

The challenge

An outdated solution that could no longer support the need for efficiency

IWA Consulting needed a new QMS solution, because their existing solution was obsolete and some of the company's workflows could no longer be supported by Microsoft.

In addition, the existing solution was based on a system configuration that was not based on standard solutions in the selected tool. This meant that any changes were dependent on the same supplier always having to step in, if something had to be adjusted.

IWA Consulting therefore had to look around for a new solution. Either you had to expand the existing one or develop a completely new solution, says Johnny Hansen.

“We did not need a new chromed solution that could add a lot of new features to us. Our requirement was rather a solution that far down the road could do the same thing - just smarter and more efficient. As we make a living by offering our knowledge and competencies to our customers, it is extremely important for us to constantly optimize the internal processes. The less time we spend on the administration of e.g. our quality assurance system, the more time we have to support our customers.

At the same time, we wanted a solution built on standard technology that would make us both less supplier-dependent and more efficient. And it was crucial for us that we would reach the goal of a new solution, before our existing solution would cease to support our flows ”.

Ongoing status meetings have been one of the crucial points for us. We have had a relatively tight deadline, and therefore it has been important for us to be close to the process.

— Johnny Hansen, Senior Director, IWA Consulting

 

The solution

An efficient QMS solution built on SharePoint

It was obvious for IWA Consulting to address IT Relation with the task. IT Relation already functions as the company's external IT department, and therefore already has a good understanding of the business.

The solution is a QMS (quality management system), which is built around Sharepoint, and especially the standard features the system makes available. Subsequently, the solution is adapted to IWA Consulting's specific needs.

“As such, it is a standard solution we have received. It should be understood in a way that most - if not all - of our needs can be met by using standard solutions in the SharePoint platform. We do not need special customizations, and we expect a solution 100% based on the features that are in SharePoint. This means that today we have a simple and user-friendly QMS that fully matches our needs, ”says Johnny Hansen.

The process around the solution has been constructive, and IT Relation has turned thoughts and experiences from previous projects with IWA Consulting before going into solution mode. At the same time, IWA Consulting has throughout the process been in the loop with ongoing constructive interaction with the IT Relation team, both the programmer and the project manager.

“Ongoing status meetings have been one of the crucial points for us. We have had a relatively tight deadline, and therefore it has been important for us to be close to the process.

The agreement has been to be available to each other - it goes both ways, of course. And we have regularly organised Teams meetings to align expectations. There has been an incredibly good dialogue here. IT Relation is good at speaking a language we understand without it becoming too nerdy, ”says Johnny Hansen.

The result

User-friendly QMS automates processes

IWA Consulting experiences that their needs have been understood and is converted into a user-friendly QMS that is implemented within the agreed time and resources.

“It is a great advantage for us that we have a QMS solution that is easy to use - even for some without much IT experience. We look forward to experiencing the value of even more processes now being automated. Now we can more efficiently get a qualitative overview of the status and efficiency of our work and deliveries to customers. It is an essential point in relation to IWA Consulting's values ​​and quality policy.

We are convinced that it ultimately benefits both our customers and our employees in relation to our value of providing good quality in our regulatory services to our customers ", says Johnny Hansen

About IWA Consulting

IWA Consulting is a leading Danish consulting house within regulatory affairs, which offers a complete range of services within regulatory and medical affairs. IWA Consulting services a wide range of international clients and specializes in eCTD applications globally. The company was founded in 1997 and has 22 specialists employed with offices in Køge and Copenhagen.

 

Are you interested in knowing more?

Marc Simonsen Taarup is the man who makes it easy to get a QMS solution that supports your business processes and minimizes the risk of errors.

Marc Simonsen Taarup

Solutions Manager

+45 5123 4699

mataa@itrelation.dk E-mail

Marc Simonsen Taarup

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