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BIOTRENDS 2020-07-06T12:26:54+02:00
Brochure BioTrends

BIOTRENDS FOR ENVIRONMENTAL MONITORING
DATA INTEGRITY

BioTrends™ is a software system developed for managing microbiological data of the environmental monitoring programs, thinked 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 program 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 UFCs identification.
The system also works in association with mobile devices with barcode readers that support operators and/or analysts, speeding up and facilitating all the aforementioned operations.
The system provides a wide possibility of creating reports and trends that represents its native function, also other interesting features such as mapping the monitored areas to highlight any “hot spots” and the management of the qualifications activities.
With an effective and simple to use sampling planner, the scheduling of daily / weekly / monthly activities can be assigned to single operators and programmed in advance. During data entry, the system will signal possible discrepancies and it will indicate when the acceptance levels are exceeded, keeping track of each operation in the audit trail.
Thanks to the management of electronic signatures on records, BioTrends can be used to manage environmental monitoring without using paper.

 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
    With the scheduler module is possible to create and manage your daily/weekly/monthly sampling plans. It also allow to you to keep under control all expiry date for media and materials, devices calibration and personnel gowning validation.
    You are able to check in real time if the sampling plan has been completed and if one point is missed. Fix the situation before it’s too late without generate deviations.
    You can follow a sample across all the process steps in real time: sampling – incubation – reading – identification.
    Obtain and use for batch release an exhaustive report product/batch related with overview of all the performed samples and their result.
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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.)

Separation of duties splits the responsibility of a critical task among different people. The method has always been needed to provide checks and balances against fraud or error, but in many companies, separation of duties has not been fully implemented and practiced. Many auditors, however, will be looking for this control technique when testing for compliance. BioTrends system provides this into its core in order to protect any responsibility on the data input and separating the activities from administration to users.Data integrity and access control issues featured heavily within the warning letters issued by the FDA since 2015; so in a data integrity-focused audit, is essential providing evidence that the analytical results are not fraudulent. BioTrends system allow you to fulfill data integrity principles summarized by ALCOA.

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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

How many time had you hear talk about “lean manufacturing”? And how many improvement cycle has been applied in your firm?
Unfortunately many times an improvement cycle is applied on a process without think at the most anachronistic element that sill survive in modern pharmaceutical company: the paper!
Requested data are always more in a pharmaceutical company. And more data means more paper.
But manual entries on paper are error prone so a big effort is requested to maintain an acceptable level of compliance and a condition of “right first time”.
BioTrends  guarantees the possibility of electronically recording of all information related to the sampling thus allowing the elimination of paper records. The whole process can be recorded without paper from the laboratory to the production department including aseptic areas where the risk of contamination is higher using sheets, pens or markers. Using our   PDA (Portable Digital Assistant) has never been so easy recording data
Remember: less paper means less errors, less deviation and less wasted time!
If you save time, you’re saving moneys!

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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
    What is the best way to make hundreds and hundreds data easy to understand? MAKE A GRAPH!
    Thanks to the Trends function it is possible to display the graphs related to all types of sampling.
    From any point displayed on the graph, is possible go back to the sampling detail, display sampling session & sampling plan that generated such graph.Thanks to the Map function it is possible to display the layout of a specific Area with the sampling points showed on, highlight the sampling points with result out of alarm levels and view the trend of a specific sampling point.Through the reports and statistics window it is possible to carry out studies and print complete reports on everything that is related to environmental and personnel microbiological controls.
    For example, it is possible to display and print the graphs and Trends of all the sampling operations performed during a given period, for a given Area, Class, etc. or to obtain the Bioburden of the entire Company or part of it
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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
    Free all the potential of BioTrends using the PDA (Portable Digital Assistant). It make so easy to track each plate from the monitoring to final reading and allow a total reconciliation of every single action performed.Using the PDA barcode reader you will no longer need sticky labels or markers inside the most critical areas of your firm. Just read the code of a sampling point and pair it with the code of a plate and it’s done. PDA help you to follow the sampling plan showing what is done and what is not; don’t forget any sampling point anymore!After sampling just pair each plates with the incubator code. After incubation period, read plates one by one and use the PDA to record CFU numbers. In this way you have a complete record of all your activities.Typically an inspector could ask:
    “how do you demonstrate that the right incubation time has been applied”?
    “how do you record Who, Where, When, …performed sampling activities”?BioTrends is the right answer!
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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
    1784    Industry 1.0 > Mechanization, steam and water power
    1870    Industry 2.0 > Mass production, assembly line, electricity power
    1970    Industry 3.0 > First computer automation
    Today   Industry 4.0 > Interconnection
    System Industry 4.0 is a name given to the current trend of automation and data exchange in manufacturing technologies. Industry 4.0 promote what has been called a “smart factory”.How your factory can be called smart if you are still using hundred of paper sheets?
    How can you be fast as the market expect if you are not able to monitor in real time what is happening in your departments?Be smart, USE BIOTRENDS!Check if the government in your country provides innovation funds!
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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

Mobile System

BioTrends Mobile empowers operators, analyst and all the staff involved in environmental monitoring programs with seamless mobile access to the BioTrends system database and carry out sampling-incubation and reading without use of paper modules or logbooks.Free your sampling activities from computer stations and paper sheets thanks to the use of wireless networks and datamatrix codes.Off-line mode is available to cover small areas not covered by WiFi signal (it can’t be considered as a full replacement of the WiFi coverage)Powered by Android OS and Qualcomm® Snapdragon™ processors that allows best in class performance, the handheld devices are built to last and assist you during your work. Made with a rugged shell but in according to the healthcare grade, they are easy to sanitize* and suitable for the use in pharmaceutical areas.They can work together with older devices based on Windows 6.5, (that are still available and supported), without request any modification in system or DB structure.  BioTrends Mobile currently support the following media plate supplier: Becton Dickinson, Biomerieux, Cherwell lab., CPC biotech, Merck, PMM. If you use an unsupported plate supplier ask him to contact us to add his code to BioTrends!

*Compatibility with VHP sanitization is under testing

SAMPLING

Operator Select the Sampling point
Operator Scan the Sampling device Bar Code
Operator Scan The Media Barcode
BioTrends™ automatically record all the information included date and time

INCUBATION

Operator Scan the Incubator Bar Code
Operator Scan all the Plates to be incubated
If the plate has not been properly sampled the BioTrends™ gives an alarm
BioTrends™ automatically record all the information included date and time

COLONY COUNT

Analyst takes the plates from incubator and scan the bar code
If the plate has not been properly  incubated the Biotrends ™ gives an anlarm
Analyst Read and digit the Result. An alarm occours if the result is higher than Alert or Action levels
BioTrends™ automatically record all the information included date and time

With BioTrends™ it is possible to manage areas in your site in a visual way through the layout management features where you can identify the sampling points in a specific area.

Through the Reports and Statistics functionality it is possible to carry out studies and print complete reports on everything that is related to environmental and personnel microbiological monitoring.
It is possible to display and print the Graphs and Trends of all the sampling operations performed during a given period, for a given Area, Class, etc. or to obtain the Bioburden of the entire Company or part of it.

When a data is out of specification, it is possible to open a deviation, send an email automatically filled with all the information like sampling point number, area involved, date of sampling, typology of deviation (Action or Alert), product batch, etc.
With the Deviation Report tool, it is possible review the list of deviation, selecting by different categories and range of time; it is possible check the status of each deviation and print out a report.

Thanks to the it is possible to display the graphs related to all types of sampling. Given that graphs are interactive it is possible, from a point displayed on the graph, to go back to the sampling detail, to display the sampling session or the sampling plan that generated such graph, to display the line representing the linear regression, to display any potential number of deviations, to compare on the same graph two or more points belonging to the same type and area, to export the graph with all its details in HTML format.

A smart user interface allow to schedule easily all the EM activity:
Single Sampling session
Daily, weekly or monthly recurrence option
Color code for sampling session status

Display alarms of expiration for:
Gowning validation
Instruments calibration
Media batch

By using the Timeline view,
it is possible to group the items by date or by Type of categories
• Sampling Session
• Device
• Culture Media Batch
• Gowning Validation

Thanks to BioTrends mobile & the Handheld device (PDA), you can speed up the whole process flow: SAMPLING, INCUBATION, READING can be performed without the use of paper worksheets, labels and pens.

Moreover, it is possible to perform in any moment the reconciliation of all samples or the media plates used and check the progress of ongoing activities

THE FUTURE HAS COME !

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Dolphin 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.

    * The suitability for VHP sanitization cycles is under testing