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Helius Customer Story

Helius Therapeutics
aces GMP audit with Scilife

  • Total GMP compliance and transparency of an all-in-one quality platform impresses auditors

  • Intuitive and interconnected software with fast learning curve sparks creativity

  • Time saved with transition to fully paperless eQMS that’s quick to set up, fully validated and responsive

Keryn Davies, Quality Manager at Helius our Interviewee for this Scilife Customer Story

 

About Helius

Helius Therapeutics is a biotech frontrunner in the new medicinal cannabis industry in New Zealand and also the country’s largest GMP certified medicinal cannabis company. The company’s vision? Health for all humanity, through one of nature’s most potent healing plants. Helius strives to be a world leader in the research, development, and distribution of next-gen cannabinoid medicines.

Keryn Davies, Quality Manager at Helius, joins our lovely customer success manager, Trine Michelsen for a chat about Helius’ journey with Scilife so far.

 

 

The Challenges

Keryn begins by explaining that the rules and regulations of New Zealand mean that all medicinal cannabis companies must be totally GMP compliant. Her primary aim when she joined Helius was to set up these necessary GMP systems and licenses. She goes on to describe that when she began she created a manual documentation system from scratch, but since it was so heavily dependent on her involvement, it was only manageable with about ten employees.


‘Our first documentation system was very manual. It relied completely on me. It was all in Word and PDFs and then you'd stamp things and send it out to everybody for training, and then you'd get them all back and you would have to copy them into different files. It was so manual!’

Keryn Davies,
Quality Manager at Helius


When the pandemic hit, and forced everyone online, Keryn reveals that it pushed Helius into making a step forward, which was the implementation of electronic signatures. However, although this helped with eliminating paper and streamlining the workflow somewhat, the company and workload was simply growing too fast to handle. That’s where her search for an eQMS for Helius began.

 

 

The Search

 

Keryn recalls that her team looked into several other quality systems, especially ones tailor-made for the cannabis industry. However, what they found was that those solutions were hyper focused on the industry and less focused on GMP regulations and optimal quality management. To Keryn, GMP compliance was her absolute number one priority, so they widened the search to include more broad life science eQMS solutions, and that’s when they discovered Scilife!

‘I wanted to solve the issues that I was struggling with because it was taking so much of my time. It was a case of identifying what it was that we were after and what we needed. What we really wanted was an out-of-the-box solution that would tick all the boxes that we needed. Something that didn't require a hell of a lot of input or expertise from us concerning validation, ongoing maintenance, or configuration. Scilife was a perfect match!

Keryn Davies,
Quality Manager at Helius

 

 

The Set Up

 

Keryn mentions that getting started with Scilife was a surprisingly straightforward process. The data and document transfers were easy, implementing the training module simultaneously was not a big deal, and creating the workflows how she wanted them was all perfectly manageable. Most importantly, Keryn stresses, Scilife was an easy platform for everyone in the company to get to grips with!


‘It went from having a system where I was basically having to hold everybody's hand for writing a document, to publishing it, to training, to being able to give a colleague a brief half hour of training and off they would go generating documents, reviewing documents, publishing them, going through their training without any assistance! It’s so intuitive!’

Keryn Davies,
Quality Manager at Helius


Moreover, Keryn delights in the fact that her colleagues now push the boundaries of Scilife and get creative with it in how they can use it to improve their work. She adds that the feedback she receives from her team is that Scilife is much more straightforward than other solutions they’ve used in the past at other companies.


‘I think that shows a system that is simplistic enough. You've got immediate uptake, but it has got enough depth to get people excited about the potential that it has as well’

Keryn Davies,
Quality Manager at Helius

 

 

Favourite Features

 

1. Interconnected modules, accessibility & speed

When asked about her favourite Scilife module, Keryn finds it tricky to choose. Each module has its own unique benefits, she says. She starts with Scilife’s Document Control module, highlighting that workflows are made much easier. She loves the immediacy of it. Keryn then praises the Events module for its structurability and accessibility. In the end though, Keryn explains, it's actually the whole of Scilife as a package that she thinks is it’s biggest strength, since it’s one single seamless interconnected system.

‘Working with Scilife is just life-changing compared to systems that I've used before. It drives you to actually be able to do your job a lot easier and more efficiently because it is easy.’

Keryn Davies,
Quality Manager at Helius


2. Audit readiness

Keryn reflects on Helius’ most recent GMP audit, which Scilife helped immensely with. Scilife is purpose-built to go above and beyond stringent audit requirements, and Keryn is elated:

‘Doing an audit with Scilife at your fingertips was amazing! Being able to pull up documents at a moment's notice and show them on the screen, showing them batch records and training records and how they are all linked. I think the auditors were just blown away at how easily we could navigate everything. They were just so impressed that it was so transparent! It was beautiful!’


Keryn Davies,
Quality Manager at Helius


 

3. Fully Validated System

Another big benefit of Scilife is that it’s fully validated, Keryn explains:

‘Scilife looks after the validation, and it's just so important. It's such a huge chunk of work that we just don't have to worry about. We reference your documents, they are concise, they've got everything in there so you don't have to spend days, weeks, months trawling through and testing something when you guys have already done it. Such a time saving there!’

Keryn Davies,
Quality Manager at Helius


4. Cost Effectiveness

Keryn mentions that Scilife’s pricing model was ideal for Helius as a small company, since it’s a pay-per-user platform that doesn’t require a large cost upfront.

 

5. Customer Care


Finally, Keryn enthuses about the extent and speed of Scilife’s customer support. She’s especially pleased with Scilife’s reactivity to fixing issues and the customer support team’s eagerness to improve the platform as a whole, for everyone.


‘Scilife is open for feedback. They don't just listen to it but actually make the changes you need. The improvement that I've seen over the short period of time is enormous. Whenever I have an issue, it gets fixed or a whole module is improved. To see functions being put in place that quickly is amazing. It’s huge.’

Keryn Davies,
Quality Manager at Helius

 

 

Expert Advice

When asked about what advice she would give to other professionals like her searching for a solution to their company’s quality challenges, Keryn answers that the right industry fit should come first.


‘I think finding a company like Scilife, who have a deep understanding of GMP and who will actually speak the language that you speak, is really important. You don’t want to have to explain the reasoning behind why you need something, which just slows everything down. Choose a system that covers all of the areas that you're after. Don’t choose one where you have to make things fit. Scilife just spoke our language. It’s built by quality people, so it talks quality. It had all the modules that we needed without requiring workarounds. It was just easy.’

Keryn Davies,
Quality Manager at Helius


She adds that selecting a platform that eliminates the need to swap between multiple systems is useful too. Another crucial factor should be that there’s a constant dialogue with your service provider, says Keryn.


‘The relationship is really key because it means that you're actually going to have something that you can continue to grow with. Being able to have that constant dialogue around what's working, what's not working, what could be better…and then actually seeing your ideas being taken on board. You're going to have a better experience from that. You don't want to be left alone.’

Keryn Davies,
Quality Manager at Helius

 

When asked about what tips she has for others starting out with an eQMS, Keryn highlights that the earlier you implement an eQMS, the better! If there’s less paper to move over, it’s just much faster. She also suggests that companies get into the mindset of being willing to do things differently and stepping away from the status quo.


Just because your company has always done something a certain way, doesn't mean you have to do it that way and that doing it slightly differently isn't just as compliant. You build in so many problems for yourself by forcing yourself down that road. Be willing to get out of your own way!’

Keryn Davies,
Quality Manager at Helius

 

 

The Results

Since implementing Scilife, Keryn says Helius has saved many hours that previously disappeared into slow, manual quality processes. Training employees is much faster too. Helius is acing audits by meeting all the GMP rules and regulations with Scilife’s transparent, compliant system, which is purpose-built for highly regulated industries. Last, but certainly not least, Scilife has managed to make quality management fun!


‘It's part of my job that I actually really do enjoy. Playing with Scilife and putting it in place and seeing what we can do with it and making it work for the team is kind of cool. I enjoy it! It's neat!’

Keryn Davies,
Quality Manager at Helius

 



Want to find out what Scilife can do for your company? Get in touch for a chat!

 

 

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