简化您的 EM 数据管理
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How is Accugenix® Tracking and Trending better than manual data entry into spreadsheets?
Automatic aggregation of data into reports in real time not only saves time but also prevents human error during transcription if you were to keep records manually. The time savings allows QC laboratory managers to focus on microbial ID data analysis instead of data management. Aside from data integrity advantages, the efficiencies gained by using Accugenix® tracking and trending are also obvious during annual product/quality reviews of EM data. Compiling and evaluating stacks of lab notes or spreadsheets can take days compared to easily accessible reports that can be available within a few clicks of logging into the customer web portal.
What regulatory guidelines show the need for trending EM data?
Both the US FDA and the European Commission recommend that a tracking and trending program is established by the manufacturers of medicinal products. The latest proposed revisions of Annex 1 show an even greater focus on data trending. Read more about the EU GMP Guideline updates in our blog post on cleanroom qualifications.
Can tracking and trending report metadata be customized?
An administrator-level user can customize data input fields and objectional organism alert lists for their facility. After initial configuration, the personalized data fields become available during the sample submission process, which translates to custom, filterable report columns. The admin user may also create an organisms of interest alert list so key personnel can be automatically notified as soon as an objectionable organism is identified.
What is the reason for trending data in EM programs?
The purpose of EM programs is to proactively monitor the microbial flora of the facility so if changes occur, contamination of final product can be prevented in time. It is difficult to detect microbial drift without benchmarking and trending EM data.