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| Biotrends is a Paperless Software System for the monitoring of the contamination controlled environments, of the raw materials and of the finished products. The system is FDA 21 CFR part 11 compliant. |
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Move to the future
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• State of the art PDA bar code solution with antibacterial external cover
• Bar code module with IOQ docs and label printer
• Reads both linear and matrix bar codes
• No need for a computer in the cleanroom
• Stand-alone solution or network solution via client-server architecture |
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Time Saving in the micro lab
An appropriate microbiological environmental monitoring (EM) program should be established and used in production and lab facilities for both sterile and non-sterile products. “In aseptic processing, one of the most important laboratory controls is the EM program” (FDA Guidance for industry, 2004).
Typical biopharma facilities may have several hundred or thousand environmental samples collected, processed on a daily basis.
Most microbial EM programs generate a voluminous amount of data and require a large amount of time from the QC labs. Companies may consider acquiring data storage and management systems.
For reference please see, Electronic Management of EM Results in the Microbiology Lab, Spotlight, September 1, 2010, BioSciences Quality Testing Forum. |
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Main Features
1. GAMP and FDA directives (21 CFR part 11) compliant
2. Simple and intuitive user interface
3. Security
• Secured Log In
• Automatic Log Off
• Audit Trail
4. Export of data in standard format
5. Electronic signatures of records (paperless)
6. Trends
• Manage and display map of areas and positioning of sampling points
• Display chart of sampling values for a give time interval, starting from the
..selection of a point in any area
• Highlight Acceptance limits on the graph by mean of different colours
• Highlight deviations
• Display linear regression line
• All related information can be easily tracked back starting from the graph
7. Management of deviations
8. Management of Bioburden
9. Management of gowning validation
10. Statistics, Analysis and correlations, including possibility to generate customized and reusable reports
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Setup Involves
• Audit functions
• User profiles
• Data input
• Import cleanroom map layouts
• Sampling points
• Acceptance levels
• Types of culture media
• Units of measurement
• Type of area
• Type of equipment
• ... and more if desired
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