BM-Windream is the 21 CFR Part 11 compliant data and document management system for the pharmaceutical industry. It is based on the market leading windream document management system from windream GmbH, Bochum. In addition to our industry-specific modules, we have access to a series of tried and tested windream add-on modules from our partner network, e.g. for e-mail archiving, linking to ERP systems, CRM systems, knowledge management or scanning solutions.
BM-Windream provides a basis for your data and document management that can be validated at relatively low cost (configurable standard software complying with GAMP5) and is easy to use. Users access your documents using a virtual network drive in Windows Explorer, which means that little training is required.
BM-Windream provides a standardised user interface over the entire life cycle of a file, from creation to deletion. At all phases in this life cycle, a change history (audit trail) is recorded.
BM-Windream is suitable for handling all kinds of non-managed documents. BM-Flow integrates directly with BM-windream and provides the document management functions required for SOP management,manufacturing instructions etc. All general employees can then still access the documents using the familiar Windows Explorer, while those responsible for creating documents can also use the workflow interface in BM-Flow.
- Centralized management of all raw data files
- Centralized management of all reports and evaluations
- Audit Trail
- Electronic Signature
- Electronic Archiving
With BM-Watcher the electronic archiving of raw data is possible for a number of laboratory devices. Normally laboratory device can just save their data files to the network drive provided by BM-windream and reprocess them from there as well. BM-windream makes sure that the data (depending on the configuration) can either not be edited at all or is version controlled when modified. BM-windream furthermore provides an audit trail for applications that otherwise would not have this feature.
Using specific rules a long term archiving may be configured. BM-Watcher automatically determines meta-data for the processed data files (e.g. project or specimen number) and assigns that meta-data to the files to serve the purpose of a search engine.
Laboratory devices normally may reprocess results from within the BM-windream drive without the need of intricate retrieval procedures. In individual cases this may not be possible. e.g. when the files are already archived and therefor write protected and the application does not support such a constellation. BM-watcher provides a built-in solution for these cases.
It is possible to use the local hard drive of computers connected to the devices and have BM-Watcher automatically synchronize data with BM-windream. If the application integrated with a device modifies data, the changes are automatically transferred to BM-windream. Automatic versioning of files can also be enforced.
These features are available for a number of laboratory systems – so you can accomplish a homogenous platform for managing raw data, whether it is from HPLC, GC, MS or images … The user does not notice any of it. He can work as usual in his familiar environment without the need of worrying about data management or long term archiving.