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Fluid Metering Finds Their Flow With INTELLECT QMS
Technology Category
- Platform as a Service (PaaS) - Application Development Platforms
Applicable Industries
- Healthcare & Hospitals
- Life Sciences
Applicable Functions
- Quality Assurance
Services
- Software Design & Engineering Services
- System Integration
The Challenge
When Nazia Khan joined FMI as their Regulatory Affairs Manager in 2015, she found that the company cared deeply about quality, but they lacked the kind of agile, flexible processes and tools that could support them in delivering consistently on that commitment, and in doing so efficiently. At that time, FMI’s quality systems were paper-based. New requests involved completing a form and physically carrying that document to various managers for signoff. Document numbering was managed using a spreadsheet, and the resulting paperwork was uploaded to an internal portal so that others in the organization could access it. Not only was this tedious and time-consuming, it also created significant challenges with respect to version control. Physical copies of the documents needed to be maintained for audit purposes, and every revision required the originals to be pulled, stamped, and refiled in a different location. Managing the flow of QMS documents was virtually a full-time job. FMI was also having trouble maintaining accurate employee training records. This, too, was a paper-based system. Employee signatures were captured on physical documents, which were retained in filing cabinets to be retrieved later if needed. Training records were manually entered into a custom Access database as well, providing an electronic record for faster lookup. Unfortunately, that database was highly unreliable, the data quality was poor, and it was only accessible to human resources and operations managers.
About The Customer
Fluid Metering, Inc. (FMI) manufactures metering pumps and dispensers for OEM, Medical, Laboratory, Analytical, Industrial Process, and Environmental Services applications. The company pioneered the first valveless rotating and reciprocating piston metering pump concept in 1959 and has continued to drive leading innovation in the industry over the years, setting the gold standard for accuracy, precision, and durability. FMI’s mission is to continually drive innovation in partnership with Life Science technology providers to improve patient health and quality of life. To fulfill that vision, the company has built a culture of responsiveness and continuous improvement, providing industry-leading service to their customers and entire value chain around them. FMI’s team prides itself on the high levels of trust and confidence their customers place in the company and its products.
The Solution
Nazia Khan and her team were charged with finding the right QMS software for FMI. She took what she called a “measure twice, cut once” approach to the process, – thoroughly researching all of the available options, talking to industry peers, and combing through software reviews from others in the medical device industry. She wanted robust QMS functionality that could address the needs of a highly regulated industry, but she didn’t want the complexity and highly prescriptive processes that sometimes come along with that. For Khan and her colleagues, flexibility and configurability were paramount. That’s why, when they first saw a demo of the Intellect QMS platform, they loved what it had to offer. Khan and her team are not programmers, and they didn’t want to hire expensive technical experts every time they needed to adjust one of their processes. With Intellect’s extreme configurability, virtually any member of the team can design and deploy new processes and functions using a no-code platform, easily adapting the software to meet their needs. Intellect was user-friendly, flexible, and affordable, and FMI found the Intellect team to be highly responsive to FMI’s questions. Intellect’s staff was extraordinarily knowledgeable about quality management, and they had direct experience with QMS for medical devices. The team at FMI also saw Intellect’s mobile apps as a strong plus, and they especially appreciated the automated flow of data across multiple QMS functions. Nazia Khan and her team selected Intellect as their new platform for QMS. They opted for a phased rollout, deploying a few processes at a time in order to better understand the software’s capabilities. As they did so, they came to realize just how powerful Intellect’s no-code platform can be.
Operational Impact
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