Relieving the Strain of Manual Quality Headaches
With over 20 years of experience in quality and biotechnology in the aquaculture space, Catherine Albert, Quality Director at Onda, knows her way around a testing site. When she was brought onboard (originally as a consultant) to help the company resurrect a recently-purchased facility, she quickly realized that for Onda to continue designing effective aquaculture studies for their growing client base, their quality processes would also need an upgrade. She further confirmed that their one-person Quality team needed help!
“When I arrived, Onda had been doing studies for 4 years,” said Catherine. “They had some quality processes in place, but they were all on paper. It was hard enough for the one full-time Quality person to manage them at one site, so it would be even more difficult to manage when they split into two different sites.”
Because Onda is a GMP, GLP certified and GCP capable CRO, the burden of one person maintaining the resources necessary to satisfy those requirements meant that change needed to happen. To help alleviate the strain, Onda decided to investigate the move to an electronic quality management system (eQMS). That’s where Catherine’s experience really came in handy.
“I was very familiar with how to roll out an eQMS because I had done it before at a previous company. I understood computer system validation (CSV) and how to determine the internal user requirements specification (URS). After I prepared our URS, I started scheduling demos with eQMS vendors.”
Even for a veteran like Catherine, the demo process was still overwhelming at times. The extra features many vendors offered were not the right fit due to complexity and cost. Onda was looking for an affordable eQMS that users of all experience levels could understand, and that’s what they got with ZenQMS.
A Right-Sized, Right-Fitting Solution
Catherine was put at ease the moment she sat down for her demo. “When I met with ZenQMS, I could tell that whoever designed it had been there before, had used a paper system, and was just trying to create a solution that people could understand. ZenQMS wasn’t more than we needed, it wasn’t a SalesForce background, it was just easy to use.”
It also fit their budget. Unlike many eQMS solutions, ZenQMS doesn’t charge by individual modules or seat licenses, allowing regulated companies of all sizes to scale up with a predictable pricing structure.
“We knew we had to find something and ZenQMS was far more affordable than every other enterprise system we looked at. But what really sold me was that we didn’t have to pay per user.”
An Organized Approach to Validation and Implementation
Once they chose ZenQMS, Catherine and her colleague got to work validating and implementing the system themselves, as Onda has no in-house IT team. They were happy to discover that ZenQMS’ common sense approach to Quality management extended to the validation process, with guidance and materials provided free of charge.
“Our biggest surprise was the ZenQMS validation checklist. I understood it because I’d validated software before, but my colleague hadn’t, and she learned so much. It was a training guide…it was as if someone at ZenQMS said, ‘This is a tool we’re giving you. Just follow these steps and you’re going to be fine when you have an inspection.’”
The two had a similar experience during implementation, which was completed in just two months.
“We wanted to get all of our documents into the system before we went live. It seemed overwhelming at first, but once we got into it, it became manageable because we had a step-by-step guide. And I’m really excited because now I understand the back-end.”
Now that the system has been fully implemented, Catherine has seen company-wide improvements, including more visibility over employee training compliance, better deviation tracking, and the ability to use the configurable Issues module to create the forms and tools that suit their needs.
“At the time, we didn’t have an HR system, so for a while, we used ZenQMS to track HR compliance. Our Group Training and OJT records were on paper and becoming a burden, so we built them into a tool in the Issues Module, along with a tool for audits. Every time we have a problem, we mull it over for a while, and then we come to this revelation, ‘Oh, we can just use ZenQMS to solve that problem.’”
ZenQMS believes that electronic quality management solutions should be easy to use, validate, and implement. If your Quality team feels the same way, visit us at zenqms.com and learn how we take the stress out of eQMS
