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Balance Data System
 Nexxis BDS™
A revolutionary new balance automation solution and data management system that provides secure and documented control over balance applications and balance data management.
Until now, balance data has been handled manually or
within insecure applications such as spreadsheets.
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Nexxis BDS automates weighing applications within a
secure environment that meets 21 CFR Part 11 compliance requirements and ensures that Standard Operating Procedures (SOPs) for all weighing applications are followed to the letter every time data is produced.
• Meets 21 CFR Part 11 compliance requirements
• Executes SOPs in a controlled environment
• Automates data management and reporting
Nexxis BDS is best understood by comparing it to a Chromatography Data System (CDS). When a laboratory purchases a chromatography instrument they typically purchase a CDS to control the instrument, collect data from the instrument, perform calculations on the data, provide reports based on the data and archive the data for historical reference. Without the CDS proper management of chromatography data would become a logistical nightmare. The CDS securely and accurately documents the entire analytical process by automating the critical functions of data collection and data management.
Nexxis BDS recognizes that weighing applications face many of the same requirements for automation of data collection and data management. SOPs need to be followed when producing data, data needs to be accurately recorded, additional calculations need to be performed on the raw data and data needs to be reported and archived. Within regulated industries all of this needs to be accomplished within a secure framework that meets or exceeds regulatory requirements such as 21 CFR Part 11.
With complete control over the SOP process and implementation of security features such as electronic signature, password protection and audit trail, Nexxis BDS is prepared to do for your balance data what CDS does for your chromatography data.
All balance data, whether collected from an instrument or entered manually, is sent directly to the Nexxis BDS server. The user-defined SOP determines exactly where and how data is stored. Each SOP process is also stored on the server. This provides the best environment for ensuring security of the data and the integrity of the SOP automation.
The Nexxis BDS client simply acts as an interactive display. The server controls the display on the client and directs the analyst through the weighing procedure based on a set of pre-defined instructions. This means that the client can be almost any type of device including desktop PC, laptop, tablet PC or PDA.
All communications with the balance is done between the balance and the server. The balance is connected either directly to the server or via a network connection. The client does not need to connect directly to the balance.
| SOP Control, Security and Regulatory Compliance |
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Nexxis BDS contains the same SOP Control, Security and Regulatory Compliance features that come standard with all Nexxis applications.
It is commonly required to calibrate balances on a regular basis. Nexxis BDS can automatically check each balance, before each process is started, to determine when the most recent calibration was performed. If the balance is due for calibration, Nexxis BDS will prevent the analysis from proceeding until it has run a calibration procedure. All calibration information is stored on the server and can be shared with other software systems.
Many labs have several different makes and models of balances. Nexxis BDS can automate applications with any brand of balance with an RS232, USB or network port. An instrument library that contains setup information for all of the major balances is included with Nexxis BDS.
| Interfacing to LIMS and other Software |
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Nexxis BDS can be used to collect data from and report data to LIMS, databases and other software applications. For example a Nexxis BDS process could query a LIMS for a list of samples to be analyzed, control the weighing process for those samples, report the weights back to the LIMS and use the Sample IDs and weights to create a worklist for input into a CDS.
| Using Nexxis BDS with Other Instruments |
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Other laboratory instruments with simple data, such as pH meters, can also be automated using Nexxis BDS. Data from these instruments can be gathered and reported in the same manner as balance data. An SOP can be created to collect, combine and report data from multiple instruments as part of a single process.
| Pre-Configured Balance Applications |
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| Nexxis BDS comes with many common balance applications that are ready to go out of the box including: |
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Check Weighing – compares the weight of samples to a required range and provides statistics for a batch of samples; standard deviation, mean, median, maximum and minimum sample, low and high percentage. |
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Content Uniformity – a set of samples is weighed and a statistical analysis of the batch is made providing the standard deviation, mean, maximum, minimum and median values. |
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Density Determination – measures the volume and mass of a sample to determine density. |
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Mass Difference – measures the initial and final weight of samples and calculates the difference in mass. |
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Moisture Analysis – calculates the moisture content of a set of samples. |
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Parts Counting – allows the user to store unit weights for a part by weighing a known number of the item and then counting unknown quantities. |
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