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Kyle Shultz is the Director of Regulatory Affairs and Quality Assurance at Cellular Technology, Ltd., an analyzer/manufacturer looking at T and B cell immunology. The organization has a manufacturing facility, as well as a contract laboratory supporting clinical and non-clinical testing. They are adherent to 42 CFR Part 493, which is part of CLIA requirements, CLEP through the New York State Wadsworth Center, and they are also accredited to ISO 9001. The organization currently has 40 Qualtrax users.

Audits are a common occurrence at Cellular Technology, Ltd., and staying audit-ready is a time-consuming endeavor for the facility. Qualtrax has simplified this process and allowed Kyle and his team to focus more on testing than audit prep.

“When an auditor comes, they know we have done our gap analysis to say that our procedures meet the requirements of what their given studies or their clinical tests are involved in,” Kyle says. “It’s going to be a great benefit for us to link those back to our procedures for them [in Qualtrax], so they don’t have to do it. They’re going to appreciate that, we’re going to appreciate that, so it will be a much more efficient audit.”

With multiple variables in play between manufacturing and testing, the variety of SOPs and training documents can create a bottleneck for quality personnel. Qualtrax has proved invaluable in helping manage the constant stream of documentation.

“When you have hundreds of SOPs and training documents to go through, it’s very difficult to review all of them in the timeframe allowed with the number of employees and staff that we have,” Kyle says. “We have to go through all of these individually before they go in the system so it’s a good way for me to make sure that all of our SOPs are getting reviewed and verified as correct before getting into the system.”

ROI is always a concern for management when assessing the value of a software-based QMS, but Cellular Technology, Ltd. has already recognized that value in time savings.

“The biggest return on investment for us is going to be the time,” Kyle says. “Because of the fact that our procedures need to be signed off and approved by many different people, it’s been very difficult to get that done with hand signatures – it takes a significant amount of time – so going to this automated, electronic system will help tremendously.”

As far as the quality of customer service, well, Qualtrax has always prided itself on delivering the best in the industry and our customers agree.

“The training process thus far has been incredible,” Kyle says. “The staff has always been very quick to reach out to us and vice versa, responding to our questions, so I would definitely recommend them for an all-in-one solution for regulatory and quality purposes.”

Categories: Audits, ROI, Testing Labs