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HOME2024-05-23T14:47:14+02:00
BioTrends EM

BIOTRENDS NEWS


BIOTRENDS FOR ENVIRONMENTAL MONITORING

BioTrends EM is a software system developed for managing microbiological data of the environmental monitoring programs, thought initially for pharmaceutical companies and improved year by year in tight cooperation with them.
The software is in compliance with FDA 21 CFR part 11.
The software has evolved over time becoming a management system for the entire microbiological monitoring process, from planning and execution of sampling to incubation, to finish with plate reading and CFUs identification.
The system works in association with mobile devices equipped with barcode readers that support operators and analysts, speeding up and facilitating all the needed operations.
The system provides a wide possibility of generate reports and trends, features such as mapping of the monitored areas to highlight any “hot spots” and the management of the qualifications (personnel gowning validations) activities. With an effective and simple to use samplings planner, the scheduling of activities can be assigned to single operators and programmed in advance.
During data entry, the system will warn about possible inconsistency and if an acceptance level has been exceeded, keeping track of each operation thanks to a well-structured Audit Trail.
Since in BioTrends EM the records are signed electronically, the use of paper is no longer needed.

 EVERYTHING UNDER CONTROL

  • Create and manage your daily/weekly/monthly sampling plans
  • Real time control of the compliance with the sampling plan
  • No more forgotten sample means less deviations
  • Total control of validation expiry for devices, materials and personnel
    Read more

ACCESS MANAGEMENT & DATA INTEGRITY

  • Full compliance with FDA CFR21 Part 11 and  EU GMP Annex 11
  • Meet auditors’ new expectations
  • Different access levels from administrator to user.
  • Clear separation of responsibility.
  • In compliance with the fundamental elements of data integrity (A.L.C.O.A.)
Read more

PAPERLESS SYSTEM

  • Electronic recording of each step from sampling to plate reading & identification
  • No more dedicated form/modules and logbook
  • Less sheets, labels, markers in critical areas
  • Less manual entries means Less errors & Less deviations
  • Save time means Save money
Read more

POWERFULL TOOL FOR REPORTS&STATISTIC GENERATION

  • Display Trend & Create reports in few click
  • Create annual reports for trend and deviations
  • Filter your data for area, department, type of control, period, everything you need
  • View result and trends directly on the map of your department
    Read more

PDA: YOUR BEST WORKING PARTNER

  • The easiest way to improve your working capabilities
  • Track all sampling steps in real time
  • Don’t forget any sampling point anymore
  • The power of BioTrends in one hand
    Read more

THE 4TH INDUSTRIAL REVOLUTION…
…ARE YOU READY??

  • Wireless connection between “The arm” (PDA) and “the brain” (Biotrends DB)
  • Smart tools for a smart factory
  • Real time interaction & control over monitoring operations
    Read more

As “in aseptic processing, the environmental monitoring program is one of the most important laboratory controls (Sterile Drug Products Produced by Aseptic Processing, cGMP FDA)”, BioTrends tracks all the monitoring process, from sampling to microbiological identification, passing through phases of incubation and reading results.

BioTrends EM® Mobile

BioTrends EM allows all personnel authorized and involved in environmental monitoring programs to work without a fixed computer and makes the use of paper forms and Log-Books obsolete, allowing them to access BioTrends EM® data and perform planning activities, samplings, incubations, reading and validation of the results, using a light, handy and small device, connected to the company network via Wi-Fi and equipped with barcode and data matrix readers. Thanks to the offline mode, it is also possible to work in areas of the plant not covered by the WiFi signal.

*Tested with more than 50 sanitization cycles with VHP

Value & Advantages

Sampling, incubation and reading by PDA >> Simplify the process monitoring
REAL TIME data recording (by PDA): BioTrends automatically records all the information included date and time
Scheduling Activities are available on the field
All worksheets & labels can be removed  >> PAPERLESS
Little time for data input, no wasting time for plate identification
Easy reconciliation of plates, sampling  >> activities Faster reaction & problems prevention
Works as a reminder for settle plates withdrawn
Expired plates cannot be used

User friendly – low training needed

PLAN

SAMPLE

RECONCILE

INCUBATE

COUNT

VALIDATE

MAP

Interface that allows you to work visually with areas and sampling points
Points can be placed and displayed on the map of your plant
You can visually highlight the out of alert or action limits for various points that occurred within a date range
By selecting a point on the map it is possible to obtain the trend of the results for a given period and view the sampling session associated with each result.

REPORTS
&STATISTICS

The module has been designed to allow investigations to be carried out on the results of environmental and personnel monitoring and on the identified microorganisms. Trends, Graphs, Reports and statistics can be viewed, exported and printed, quickly and easily, by Areas, Classes, Types of points, Types of Results or by building more complex filters.

DEVIATION

When a data is out of specification, it is possible to open a deviation, send an email with all the relevant information like sampling point number, area involved, date of sampling, typology of deviation (Action, Alert or other events), product batch, etc.
With the Deviation Report tool, it is possible to review the list of deviations, filtering them by different categories and ranges of time as well check the status of a deviation and print out a report.

TRENDS

This module allows to display the charts related to all types of samples. Thanks to the interactivity, clicking on the points displayed, you can view the sampling details, recall the original sampling session, display any related deviation, compare on the same graph two or more points and export the charts.

SCHEDULER

Smart user interface that allows to plan, view and monitor the activities in a calendar style.
Sampling sessions can be scheduled as recurrent (daily, weekly or monthly) or one-time.
The progress state of the sampling session will be indicated by a different color.
Display alarms for expiration of gowning validations, instruments calibration and media batches.

INSTRUMENTS
INTERFACE

Modules that allow to establish a direct interconnection between the devices used for environmental monitoring and BioTrends EM, increasing the efficiency and reliability of the data.

THE FUTURE HAS COME !

THE CHOSEN DEVICE OF EXCELLENCE

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Honeywell CT40 HealthCare

  • POWERED BY ANDROID OS
    BioTrends Mobile is now available for Android OS devices.
    In this way it is possible to use the best in class handheld devices available on the market, also in rugged and healthcare version.

  • POWERFUL
    thanks to the complete restyling of the software structure, BioTrends Mobile can make the most of the Android platform and the power of the most advanced devices on the market, massively increasing its performance in the field

  • USER FRIENDLY GUI
    The graphics have been completely renewed while retaining
    the previous concept. In this way, even the “old users” will immediately feel at home and will be able to immediately use the new devices just “out of the box”.
    Thanks to its user friendly GUI, BioTrends Mobile assure a fast learning curve for the new users too

  • EASY TO SANITIZE
    thanks to its soft and essential lines and the full-screen design without the physical keyboard of the new PDA, sanitization is now easier and more effective.
    Made with a rugged shell but in according to the healthcare grade, the PDA are suitable for the use in pharmaceutical areas and tested against the
    more common sanitizers like Isopropyl Alcohol, Hydrogen peroxide and sodium hypochlorite.

    * Tested with more than 50 sanitization cycles with VHP

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