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.
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:
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-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.
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.
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.
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 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.
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 (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.
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.
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.
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.
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).
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.
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.
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.