iMIX is a pharmaceutical company based in New Zealand that provides tailored medicines directly into hospital settings. To illustrate, imagine a doctor is treating a cancer patient in a hospital and places an order for a selection of different prescriptions. iMIX will receive this order, put the drugs into a saline or glucose bag, and send them over to the hospital within one or two days.
“The turnaround is very quick and very different compared to a standard pharma approach,” explains Gareth Quinn, Director of Quality at iMIX. “Traditionally, a pharma company might take weeks or even months to make a batch. We’re looking at hours.”
Due to the speed at which the company needs to operate and the high stakes that come with treating hospital patients, iMIX needed a robust electronic quality management system (eQMS) to ensure that every product it shipped met the highest quality standards.
“If we release a new product or new drug, I’m responsible for that,” Quinn explains. “Legally, if something goes wrong, I can be called in to deal with it.”
Not only would the right eQMS system protect the company against liabilities, it would also make it easier to pass audits, which are conducted regularly by Medsafe, New Zealand’s FDA-like regulatory agency.
To meet its goals, iMIX needs to balance its commitment to high quality standards with the ability to operate with agility.
“Because the company is growing very quickly and gaining new business all the time, we have to be quite innovative,” Quinn continues. “Frankly, this is one of the key reasons we went with Qualio as our eQMS.”
Over the course of his career, Quinn has worked with a number of multinational pharmaceutical companies, many of which were using well-established QMS solutions. As the iMIX team began looking for a solution, Quinn steered them as far away from these options as he could.
“I was careful to avoid too much complexity in a system we adopted,” Quinn says. “Whatever system we went with needed to be easy to start using and it needed to be intuitive so I would have engagement with the team very quickly.”
After researching his options, Quinn found Qualio and loved what he saw. Budget costs and time to implement the system weren’t the most influential factors in reaching a decision, but Qualio’s price point and ease of implementation made the choice even easier.
At the time of this writing, iMIX hasn’t yet fully implemented Qualio into its operations. But the company is very close. Per Quinn, the process has been seamless — and much faster than he expected.
Already, iMIX is confident they made the right decision about an eQMS. Here are some of the benefits they’ve already experienced as a result of their decision.
In previous roles, Quinn has spent upwards of a year or even longer implementing new QMS solutions. The process of migrating to Qualio is almost complete, and it’s only taken a couple of months.
“I’ve fed this information back to my colleagues at my old company: I’m working with Qualio, this company is unbelievable, we’re so close to going live, and it’s only a matter of months,” Quinn says. “That for me is absolutely massive from an ROI perspective alone.”
When any pharma company decides to move to a new QMS, they’re doing it for a reason — likely because they’re running into problems.
“The difference with Qualio is that you can fix those issues way quicker.”
Due to the high risk levels associated with the products they make, iMIX is routinely audited by Medsafe. When the company passes the audit, its certifications get renewed.
“With Qualio, we’re in a good position,” Quinn says, adding that the next audit iMIX will face will be even stricter than previous ones. “They’re asking for more efficiency and more removal of risk from the system. This was another driver for bringing Qualio in.”
Qualio enables the iMIX team to move beyond paper-based systems. As a result, human error is largely taken out of the equation. Now, the team can rest comfortably knowing that documentation is accurate and easily located at any given time.
As a result, the iMIX team will have a much easier time achieving certifications for different drug classifications as they expand their product portfolio.
“Having strong quality systems in the background to help you focus and get you through the audits is really powerful,” Quinn continues.
Quinn is familiar with some of the bigger-name QMS systems on the market today.
“On paper, they are really good, powerful, and strong,” Quinn says. “But there’s just so much complexity in there.”
For Quinn, Qualio is beautiful in its simplicity; he believes that new hires who didn’t know anything about the industry could get up and running on the platform in short order. The same couldn’t be said if that new hire were thrown into one of the more comprehensive and rigid solutions on the market.
“I wanted a system that was quickly learned, quickly trained, and expandable, and Qualio hit all of those needs.”
As Quinn was searching for a solution, he did a lot of research on the web, and he talked to a bunch of current and former colleagues about newer solutions on the market.
“Qualio came across strongly online,” Quinn says. “When I asked for specifics—ROI, case studies, testimonials—everything that came back to me looked really good.”
What’s more, Quinn has been very pleased at all of his interactions with the Qualio team.
“They’ve all been terrific,” he says.
Older QMS systems require a lot of annual maintenance, which takes up a lot of time and effort.
“Just the day-to-day of using the system is pretty onerous for me,” Quinn explains. “Some of the older systems are very heavy, and it’s hard to find what you need.”
With Qualio, iMIX has a system that can keep pace with their growth while taking tasks off the team’s plate — thereby enabling them to get more done every day.
“This will make people’s lives easier and build huge efficiencies for us,” Quinn concludes.
For more information on iMIX, visit https://imix.nzt.
To learn more about how Qualio can help your pharmaceutical or biotech firm bring products to market faster and streamline regulatory compliance, request a demo today.