From Disconnected Records to Audit-Ready Quality
How sterilizable packaging provider, Technipaq, Inc., strengthened control with QT9 QMS.
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Industry
Sterilizable Packaging Solutions
Founded
1984
Location
HQ: Crystal Lake, IL
Employees
180+
Now I can handle each and every single audit 99.9% of the time completely by myself. … Audits end early because everything is clean, everything is crisp, everything’s in order.”
- Tara Arient
Quality Director, Technipaq, Inc.
Eliminating Disconnected Records for Greater Control
Technipaq provides the flexible, sterilized packaging that healthcare, medical device, diagnostic and pharmaceutical companies rely on to protect their products. Maintaining ISO 13485 certification, Technipaq’s work requires extensive documentation and quality control throughout their operations. Yet, when Quality Director Tara Arient came on board, its quality operation ran on paper and shared drives. Individual records could take 20 to 30 minutes to locate, approvals were harder to track, and quality staff often had to involve subject-matter experts simply to retrieve information. Shared files also created revision-control risk. In fact, an internal audit found a department using an altered form rather than the current approved version, reinforcing the need for tighter control.
Finding One Connected QMS Platform
The ability to use QT9 QMS largely as delivered was a major reason Technipaq chose QT9 over other solutions. The company wanted a configurable system that could meet its requirements without extensive custom development or the validation and maintenance demands that often come with it. Taking advantage of QT9’s user-defined fields gave the team enough room to configure workflows while staying within the system's standard operating conditions.
Today CAPA, engineering changes, nonconformances, deviations, supplier and customer records, documents and training all live in one linked system, where every related quality event sits a click away from the customer or product it touches. By avoiding custom software configuration, validation and maintenance tasks stay light. After QT9’s team helped implement the first modules, Technipaq was able to self-implement the rest.
Faster, Cleaner and Audit Ready
Implementing QT9 QMs has given Technipaq greater visibility, speed and control. The team has real-time insight into every process, pulls data faster and enjoys automated approval workflows and electronic sign offs. Technipaq’s 25 to 30 customer audits a year, plus its notified body audit, are handled almost entirely by one person and often finish early. Centralized document control minimizes risk, with records easily tracked and instantly retrievable for improved traceability.
Challenge
Eliminating disconnected records for greater control and audit readiness.
Solution
One connected QMS platform, ready from the start.
Results
- 80% decrease in audit prep time
- 70% decrease in administrative time
- Overall increase in visibility and accessibility across the company to all quality processes
About Technipaq, Inc.
Technipaq has been providing flexible, sterilized packaging solutions to the world’s leading healthcare, medical device, diagnostic and life sciences companies for more than 35 years.
They are a leading single-stop supplier capable of laminating, printing, slitting, sheeting, die-cutting and fabricating flexible sterilizable bags and pouches customized to design needs and delivered under the most demanding timeframes.
An ISO 13485 certified manufacturer with more than 100,000 square-feet of production and warehousing space, Technipaq produces and maintains an extensive selection of custom stock laminates, in both peel-able and fusion-seal formats, allowing them to produce orders of any size on-demand.
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