WATCH+

Decentralized intelligent agents execute defined missions that correspond to actual stages of defined cloud-based business workflows, carrying capabilities to ensure end-to-end compliance.

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Monitor the file storage of your laboratory device

biomedion WATCH+ is an Add-On for neuronOS platform applications and integrates an 21 CFR Part 11 compliant raw data management solution for the pharmaceutical industry. The Add-On integrates meta-data and raw-data of nearly all types of laboratory instruments and handles also clinical data structures like trial management data and master files (eTMF). WATCH+ provides data integrity features even for legacy systems. The necessity for end-to-end compliance and data integrity drives our solutions towards decentralization.

That we still see a growing number of inspection findings in the category data integrity gives us the motivation to further develop solutions which can ensure and end-to-end approach to quality and data integrity. 

biomedion WATCH+ works as a decentralized agent service that is able to monitor a local file storage of an actual  laboratory device. Based on configurable business rules WATCH+ will etract meta-data, make them available to busines processes and handle the raw-data according to life cyle stage, business rules and storgae capabilities. Endpoints can be on premise storage, ECM systems (Windream), cloud- or hybrid storage (AWS) as well as archiving systems with hierarchical storage. WATCH+ detects events, applies rules and acts autonomously in the background as a validated service. 

The capabilities of WATCH+ for automatically retrieving metadata, e.g. from file paths, text files or proprietary file formats and databases enable this mechanism to support business processes from early development to archiving. These workflows can involve triaging or simple quality checks and simple annotations up to full blown business processes on the neuronOS platform. All files are provided with an audit trail and versioning, so that changes can be traced.

 

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21-CFR-part-11

 

  • Decentralized agent services monitor file transactions on local or remote file systems
  • Integrated with archive management (ARC+) for long-term archives or interface to existing archives
  • Audit trail of all file transactions, context of user logged on to the system
  • Archiving in cloud storages, i.e. Amazon S3/Glacier
  • Mirroring of local and cloud archives
  • Creates versions of files in case of any changes
  • Capabilities for tracking modification reasons (if not handled by the laboratory instrument)
  • Extracts meta data from original files, file names, accompanying file (like sequence, job list, ...)
  • Extracts meta data from external databases, i.e. LIMS or MES
  • Simple, fast and powerful search
  • Supports reprocessing directly from the archive in many cases
  • Integration of converters (AniML, ALLOTROPE, ...). 
  • WATCH+ agents can act offline and resume transfers, when connections are back or according to schedules. 
  • Digitally signs files automatically, detects unauthorized modifications. 

Monitor the file storage of your laboratory device

  • Access control
  • Audit trails
  • File versions
  • Electronic signature Lifecycle
  • Automated indexing of all data
  • Integr. electr. long term archive
  • Instrument monitoring
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BM-Windream

Enterprise Content Management System

BM-Windream consists of the application server, a long-term archiving system and various clients for different operating systems (Windows, iOS, Android).

The Windows client presents itself as a drive with extended functionality to the operating system. Users can use this drive like any other local or network drive, e.g. in the File-Save dialog of an application or in Windows Explorer.

An object type defines metadata (attributes) and the behavior of the file, e.g. regarding the possibility to change the file after creation and long-term archiving rules. Once an object type has been assigned, it is possible to lock the file against changes, even by authorized users. In this case, changes can only be made after a new version of the file has been created.

BM-Windream integrates with the Windows Active Directory for user and entitlements management. Users logged on to Windows are automatically recognized. Various roles are supported, such as main user, administrator and user.

The files are saved in their original format. In addition, it is possible to convert files automatically, e.g. to PDF or AniML, if the respective converters are licensed. The original files are retained if desired.

BM-Windream supports searching based on captured metadata (applies to both manually or automatically assigned) The metadata can be freely configured, including complex scenarios:

  • Multiple selection lists with dynamic values (based on database queries)
  • Dependent multiple selection lists (selected value of one list defines the value range of another selection list, e.g. the selected value of the "Location" selection list determines the value set of the "Department" selection list)
BM-Watcher

Monitoring Agent

BM-Watcher is a data collection tool that is able to monitor laboratory instrument data repositories. Directories to be monitored can be defined. BM-watcher is event driven and responds to files system triggers. For example, BM-Watcher can copy files at each occurrence of a file creation event. Files can be copied to BM-windream, or a new version of a file can be created at a file change event if so configured. The behavior of the BM-Watcher is configurable in a wide range, e.g. delay copy actions or make them dependent on the creation of another file. This is useful if the laboratory instrument software initially creates files with rudimentary content and then gradually adds measurement results.

Another function of the BM-Watcher is to determine the attributes belonging to a file. These can be read out from the measurement data, path information or linked databases. When the data is transferred to BM-windream, the attributes are transferred as well.

BM-Watcher must be installed on the to be monitored laboratory device. This procedure ensures that files can be archived very quickly, triggered by file system events. Additionally, this approach allows for user interaction, e.g. present the user a dialog box in case of data changes, to record reasons for the changes.

The BM-Watcher is administered by a central configuration server. This enables the compilation of modules (e.g. monitoring, determination of attributes, comments and log files creation) and their configuration via XML files. All configuration changes as well as all file transactions are subject to an audit trail. Since the complete functionality of the BM-Watcher is implemented via modules, the configuration server allows for the execution of updates.

BM-Watcher-Screenshot

 

INTEGRATION

BM-WebLink

BM-WebLink enables the creation of Permalinks, enabling URL-based access to data in BM-Windream from a web application. Permalinks (URLs) remain stable even if the files are archived or moved in the virtual file system. Permalinks can be created, for example, via a corresponding entry in the Windows Explorer context menu or from a BM-Windream search results list.

BM-WebLink enables the integration with web-based ELN or LIMS systems.

Instrument Integration

BM-Watcher has been designed to capture files from file-based applications like HPLC, GC and microscopes. Small databases can be handled as well. It is not designed to capture data via RS232 or USB.

Our experience shows that the pure archiving of files can usually be set up quickly and easily for most laboratory devices. Based on our many years of experience, BM-Watcher now offers all necessary configuration options, e.g. delayed archiving or archiving after the creation of a final file.

However, the correct determination of attributes involves a certain amount of effort in each individual case. There are many special cases, such as naming conventions for folders or files, which must be taken into account. These cases can usually be mapped but require a certain amount of effort in configuration and validation and, if necessary, adaptation. However, we cannot make a general statement of compatibility due to this.

COMPLETE FLEXIBILITY TO BRIDGE THE ENTIRE PROCESS END-TO-END

Various flexible Add-ons emphasize fully flexibility, collaboration and compliance to bridge the entire process end-to-end

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