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BioTrends(TM) is a software system that assists QC Microbiology personnel with the collection, trending, and reporting of data from cleanroom environments. This data collection occurs in both raw material and finished product environments. The system is FDA 21 CFR part 11 compliant
The sampling conducted by QC Microbiology to highlight the possible presence of molds, yeasts and bacteria, produce a considerable amount of data that BioTrends manages in a simple and accurate way.
The collection of data sampling is done in a structured way through the sampling plans defined by the appropriate management personnel. A sampling plan will contain elements organized by the type of control required (air, surfaces, water, compressed gas, personnel etc.).
The activities of sampling and analysis may be allocated to individual operators and planned in advance. During data entry the system will indicate any deviations to action and alert limits and will record every operation in the audit trail.
Data can be accessed by the trends window, as well as the reports and statistics window. From here you can make inquires and see trend charts or print and export complete reports. Thanks to the electronic record signatures, Biotrends allows you to manage your environmental monitoring process without using paper.
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Trends
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• Visualize trends over time
• Compare two or more different sampling points in a room over time, on the same chart
• Action/alert levels and deviations are easily noticeable on charts
• Each graph offers the possibility of retrieving information such as microorganism identification and which production batches are involved with the sample
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Reports & Statistics
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Statistical summaries of results, by sampling location, are available as well as bioburden information. |
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Annual reports
A few clicks will let you print the annual trends of all sampling points grouped by type of sample or location.
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Deviations / BioBurden
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| Sampling points can be graphically represented on the layout of the factory, in the respective area where they belong.
With BioTrends, it is possible to obtain all required information such as Trends, Deviations, BioBurden relative to one single point or to wider areas, starting from their graphic representation as shown on the layout. |
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BioBurden
Data can be accessed by the trends window and the reports and statistics window, through which you can see trends charts, make inquiries, print or export complete reports. Thanks to the electronic signatures of the records, BioTrends allows management of monitoring without using paper.
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BarCode System
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• State of the art PDA barcode solution
• No need for a computer in the cleanroom |
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