SOP Managemen and Quality Management

SOP Managemen and Quality Management

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.

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