ON PREMISE

RAW DATA ARCHIVING MADE EASY

Monitor the file storage of your laboratory device

BM-Watcher

biomedion BM-Watcher is a 21 CFR Part 11 raw data management solution for the pharmaceutical industry. It integrates with nearly all types of laboratory instruments. It is able to provide data integrity features even for legacy systems.

biomedion BM-Watcher is an agent that is able to monitor the file storage of a laboratory device. New or modified files can be transferred to BM-Windream (our Enterprise Content Management System). When changes are made, new versions of the file are created automatically.

BM-Watcher is also capable of automatically retrieving metadata, e.g. from file paths, text files or files in proprietary formats and databases. Reasons for changes can also be requested from the user. In BM-Windream all files are provided with an audit trail, changes can be traced via the versioning of the files.

21-CFR-part-11

Agent monitors file transactions on local or remote file system
Integrated long-term archive or interface to existing archive
Audit trail of all file transactions, context of user logged on to the system
Archiving in cloud storages, i.e. Amazon S3
Mirroring of local and cloud archive
Creates versions of files in case of any changes
Keeps track of reasons for modifications (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, ...) feasible
Agent even handles offline case.
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

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.

Related Processes

Audit Management

The increasing complexity and continuous changes in the regulatory environment push organizations to seek a more holistic and highly integrated approach to their audit management processes. Auditing is a vital function within a pharmaceutical company.

CAPA Management

To understand how to achieve quality in a regulated industry, you need to know that corrective and preventative actions (CAPA) are essential elements of quality management in GxP environments. The CAPA process is a commonly used tool to achieve operational excellence by identifying and mitigating non-conformances and deviations, both internally and externally.

Change Control

Change management is specifically designed to evaluate, redesign, and implement new business processes, where processes are defined in standard operating procedures (SOPs). A well implemented change management rewards the company with improved business processes, efficient workflows, decreased project overhead, a better risk profile and an improved company culture.

Deviations Management

The management of deviations is not just a GMP concept, it spans the entire product life cycle, including Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) and Process Deviation Management.

High Content Screening

High-content screening (HCS), also known as high-content analysis (HCA) or cellomics, is a method that is used in early development stages and drug discovery to typically identify substances such as small molecules, peptides, or relevant RNAi that can lead into development candidates for future medicines.

Image Annotation

With the development of diagnostic imaging devices, large amounts of digital high-res and 3D images are generated every day. The requirements of effective indexing and searching image are growing rapidly. Image annotation is an effective way for content-based image retrieval.

CRO Collaboration

The last few years have seen tremendous consolidation in both the pharmaceutical and contract research industries. The impact among pharma companies has created a heightened demand for productivity.

Remote Image Analysis

Imaging data in diagnostics and research is growing at an unprecedented rate, coming from all kinds of sources. The con-focal and high-resolution microscopy, artificial intelligence, and any other new computer-tomographic (CT) technologies create vast amount of data. When researchers start to collaborate over distances with imaging centers, using diagnostic services over internet connections, the bandwidth and computation power easily exceeds the capabilities in remote areas.

Inspection Management

Regulatory agencies conduct routine inspections during active studies. In this case, documentation must be available and complete, ensuring that the study was conducted following the protocol using the principles of Good Clinical Practices (GCP).

SOP Management

Life science organizations developing or manufacturing pharmaceutical products will typically create, maintain and execute large amounts of standard operational procedures (SOP). The solid change control and deployment of SOPs are a fundamental to achieve compliance excellence.

Raw Data Management

A clear understanding of how RAW DATA is defined, recorded, and retained in the laboratory record is essential when it comes to compliance with the Good Laboratory Practices regulations. RAW DATA in laboratories occur in various fluctuating formats and versions in a large amount of laboratory devices, LIMS and quality management systems.

Training Management

Post implementation training services relate often to process changes. With training services implementations are ready for success. The Learning Management System (LMS) typically handles the processes related to ramp-up and adoption planning after larger implementations.