CSB-System Optimizes Quality Management at DiaSys
Leadership - DiaSys Diagnostic Systems is a leading specialist in the development and manufacture of diagnostic systems of high quality combined with ease of use and reduced environmental burden. Focusing on clinical chemistry and immunoturbidimetric tests, DiaSys has introduced more than 80 optimized reagents for routine and special diagnostics. In addition, the product range includes a large selection of suitable calibrators and controls as well as photometric systems and glucose/lactate analyzers.
DiaSys has been ISO certified since 1996 (valid certificates ISO 13485:2003, ISO 9001:2000) and was one of the first diagnostic companies to label its products with the CE mark from June 2000 onwards. Today, customers and partners in more than 100 countries around the world rely on DiaSys quality.
CSB-System Manages Business Processes
The diagnostics specialist from Holzheim , Germany, has been using the CSB-System since 1997 as industry-specific software solution for comprehensive management and control of its business processes. Alexander Schwarz, IT Manager, knows all the benefits: "The flexibility of the CSB-System allows us to utilize this IT solution according to our requirements. Together with CSB-System consultants, we tailored the software to optimally suit our company and our processes. We were able to considerably reduce IT administration costs and to noticeably accelerate the processes in many areas."
Quality Management as Project Focus
DiaSys currently optimizes its quality management with the help of CSB-System:
"We are reworking our processes in cooperation with our IT partner in order to be able to finally map them in their entirety. Our objective is to realize paperless quality management, which provides us with quality-relevant data from all areas in next to no time," Schwarz said. In doing so, DiaSys requires dynamic test plan management to economically manage the entire inspection scope, including e.g. the optical density of diagnostic agents, the activity of enzymes and the ph-value. The ph-value, for example, must be within a specified range and must not change during the defined life of the guaranteed specifications.
Tests According to Predetermined Parameters
The reagent "CRP-FS"," for example, has a life of 24 months and is being used successfully in heart and rheumatism diagnostics. Here too, the optical density must be within closely predetermined limits. Transparency and the wavelength of the light, in particular, are used as the main test parameters. The acceptable values are recorded in the CSB-System and can be retrieved at any time: "Based on the recorded values and the predefined test plan, the CSB-System will immediately notify us about any discrepancies, should the values be outside of the tolerance. This increases safety and saves time that we previously had to spend on unnecessary red tape for our quality controls," Schwarz said.
Practical Example: Cholesterol FS
With the diagnostic agent Cholesterol FS, DiaSys is making a great contribution to the quick identification of high cholesterol level. DiaSys purchases the raw materials for the cholesterol diagnostic agent and tests them during delivery control with support of the CSB-System. The test specifications are stored in the CSB-System and are processed at goods receiving.
During this time, the raw materials are kept "in quarantine" and can not be used. If the tests are successful with no objections found, the CSB-System carries out a stock transfer of the raw materials and marks them as "approved." The raw materials are then posted to a warehouse for approved materials and can be used for batch production. Batch preparation follows a clearly defined manufacturing procedure and is reported to the CSB-System. Quality control takes the specified sample and performs the tests as listed in the test plan displayed by the CSB-System. Final approval of the cholesterol diagnostic agent can be given, if all required specifications have been met.
Secure product traceability is essential for diagnostic agents.
"With the CSB-System we can guarantee transparent traceability back to the original batch of the raw material in an extremely short time," Schwarz said. One master batch per component, made up of many raw material batches, is predefined for the production of reagents. This master batch accompanies the product throughout the entire production process. If a customer reports a suspicious batch number, DiaSys can quickly trace the origin of the raw materials.
"Utilizing the CSB-System, we can determine the origin of the suspicious batch in less than 60 seconds. This provides extensive safety to us and our customers. Traceability into the past and across all batches that have so far been produced is available at any time," Schwarz said.
DiaSys intends to stay among the leading diagnostic companies worldwide and will therefore continue to rely on the industry expertise of CSB-System.
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