Environmental Monitoring Analysis and Data Management
Highly regulated industries are required to establish comprehensive and reliable quality systems and environmental monitoring programs that measure the state of control of their manufacturing facility and ensure data integrity. This state of control can be demonstrated with the Accugenix® environmental monitoring data management tracking and trending reports. With the Accugenix® 21 CFR Part 11 compliant environmental monitoring tools, users can import and export organism data with detailed records of identified species, frequency of occurrence, and other aggregated information for analysis.
Webinar: Tracking and Trending Made Easy
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Explore Interactive Accugenix® Tutorials
Click through the links below for examples of how the Accugenix® Tracking and Trending reports can provide actionable information for operational decisions.
7 EM Data Challenges
- Challenge #1: Number of Molds Identified
- Challenge #2: Finding Common Organisms Identified
- Challenge #3: Organisms to Include in a Challenge Panel
- Challenge #4: Investigating a Contaminant
- Challenge #5: Tracking an Increase in Gram Negatives
- Challenge #6 : Evaluating EM Data Based on Gram Reaction
- Challenge #7: Evaluating Frequency of Occurrence and Seasonality
- Additional Tutorials
View All Your Microbial ID Data in One Place
Tracking and trending features within our web portal can streamline how you manage your EM data. See How It Works
"I love how you can see in the home page as soon as we sign in the trending data of the past three months and the frequency of occurrence of the microorganisms. This has helped us identify faster our most common microorganisms in order to perform cleaning efficacy testing and choose the correct cleaning agents for our cleanrooms."
— Quality Control Coordinator, health services industry, Tukwila, WA
Our data trending solution provides a record of all environmental isolates identified with Accugenix®. Recent enhancements also include tracking and trending customization features for data entry fields and report parameters while meeting requirements of 21 CFR Part 11 and GAMP5 standards. The Accugenix® Customer Web Portal allows users to demonstrate the state of control of their manufacturing facility through the tracking and trending and environmental monitoring tools.
Frequently Asked Questions (FAQs) about Tracking and Trending
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.