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 personnelWith 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.
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.
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!
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 departmentWhat 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
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 handFree 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!
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 operations1784 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!
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
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 fieldUSER 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 tooEASY 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