See why TriRx implements ZenQMS in its GMP manufacturing sites
TriRx Pharmaceutical Services, headquartered in Norwalk, Connecticut, acquires large, captive GMP facilities that manufacture active pharmaceutical ingredients or drug products from pharma companies, and converts them to stand-alone contract manufacturing sites. These are complex engagements governed by transition service agreements, which enforce strict timelines for separating key systems from the original owner’s technical infrastructure.
The scope of these transitions varies, typically including all critical systems for managing production, accounting, labs, and quality management systems (QMS). Scott Harris, Vice President of Information Systems at TriRx, has managed many of these transactions, and he knows that a successful transition for the site and its staff depends on maintaining the status quo with the same tools or better ones, with as little friction in data/license transition as possible.
The quality management function at these sites encompasses document management, training, CAPA, and change control. For Scott and his team, in addition to easy implementation, it’s critical that the quality system the site moves forward with is easy to use and works within their budget. Because the clock (and the window of potential profits) starts as soon as they move into a new site, TriRx only has a few months or less to validate and completely install an eQMS. “I’ve used other big systems and there’s no way you can get them up and running and learn how they work in 3 months. I continue to put ZenQMS in my sites because it’s so easy to use and their customer service is great.”
Stephanie Valachovic, Project Manager at TriRx agrees. “A lot of these sites have bulky systems that I call ‘administrative bears’. They take up so many resources.” Those resources drive up administrative costs and create delays that are unnecessary with a more efficient eQMS.
Scott has implemented ZenQMS at more than 11 different manufacturing sites around the world over the last six years. That’s because ZenQMS meets his simple, but critical requirements:
- Easy to understand
- Easy to install
- 24/7 responsive customer service
“I continue to put ZenQMS in my sites because it’s so easy to use and their customer service is great.”
Lackluster customer service with other systems is something Scott is glad he’s put behind him. “A lot of big companies...they’re happy to take your money, but if you ask for something that’s not already in their system, they’re not going to give it to you. They won’t work with you.”
It’s fair to say that getting help with ZenQMS has never been an issue for TriRx. “ZenQMS has, by far, the best online help I’ve ever seen from these systems, including Microsoft,” says Stephanie. “And as far as administrative tasks go with ZenQMS, you almost forget you have to do anything because there’s so little of it. After you get it set up, the system practically runs itself.”
“We’ve come to ZenQMS with some ridiculous challenges and timelines and we wouldn’t have returned if the staff weren’t outstanding to work with,” adds Scott. “Every single time I’ve said, ‘Here’s our challenge, can you help us?’, they’ve absolutely jumped on board.”
TriRx has experienced a significant measure of operational leverage not possible with other eQMS systems. “We’ve never needed a full-time ZenQMS system administrator at any site. It’s always been a part-time role that takes 10% of their time, and even that might be an exaggeration,” says Scott. To that end, ZenQMS provides TriRX with significant returns through reallocation of resources which they previously needed to chase after staff for signatures, training, etc. Those staff members are now free to focus on other more valuable activities.
For Scott and Stephanie, ease-of-use matters most, especially for general staff who are infrequently in the software. Even the very best technical solution will fail if no one knows how to use it and support is difficult to find. Too often, IT and QA teams are conditioned to believe that ‘complexity’ and an increased cost equals a better solution, only to find the opposite is true—fancy bells and whistles wind up being wasted and the system is too difficult to maintain to provide any value.
Scott has seen this occur at different sites around the world, which is why he continues to work with ZenQMS. “I believe that within 30 days, after things are ironed out and everything is validated, there’s not a single site or person who regrets using ZenQMS. I’ve recommended them to a number of companies as well because of how impressed I am with them.”