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.
is a 21 CFR Part 11 compliant data and document management system for the pharmaceutical industry. It is based on the market-leading document management system windream by windream GmbH. In addition to our industry-specific modules, we can also rely on a multitude of tried and tested windream add-on modules from a partner network, e.g. for e-mail archiving, connection of ERP systems, CRM systems, knowledge management or scan solutions.
supplements its BM-Windream system with functions for document control (for example SOPs, batch records, test plans, validation documents and many more) and the management of typical quality management processes (for example deviations, Out-Of-Specification, complaints and others). Thanks to the high degree of integration possible with BM-Flow, you always have an overview of all processes and their interrelationships.
Computersystemvalidation for the pharmaceutical industry
IT-compliant - 21 CFR Part 11 - EU GMP - Annex 11 - ISO:9001 - ISO:13485
CAPA/deviation management, trainings management (QMS), raw data and document management (DMS) for the pharmaceutical industry
BIOMEDION provides solutions for document and raw data archiving3 for pharmaceuticals and other industries regulated under 21 CFR Part 11.
BM-Flow is a standard product for SOP management, training management and management of other managed documents (qualification plans and reports, computer system validation documents, maintenance logs etc.). It can be used in all GxP areas, but also in ISO:9001 or ISO:13485 certified companies.
In quality assurance, BM-Flow supports typical QA processes such as change management, deviations, specification deviations, complaint management and preventive and corrective actions. It also enables other company-specific processes to be mapped easily, and all processes can be extensively adapted to meet the customer's needs.
BM-Watcher supports raw data archiving. BM-Watcher automates electronic long-term archiving of raw data from a range of laboratory systems. The user can work on the equipment as normal and BM-Watcher automatically transfers the data to the archive, and automatically extracts the meta data from the raw data.
Integration of both products with BM-Windream allows central management and long-term archiving of all data and documents, along with electronic long-term archiving as part of an "Enterprise Content Management" system. Additional modules can be used to map non-regulated processes in marketing and sales, human resources, mailbox management, management of accounting documents, e-mail archiving etc.
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 wi... » more
BM-Flow supplements your BM-Windream system with functions for document management (e.g. for SOPs, manufacturing instructions, test plans, validation documents etc.) and management of typical quali... » more
Provides electronic management of all kinds of managed documents, e.g. SOPs, qualification documents, manufacturing i... » more
The training module of BM-Flow supports you in keeping abreast of these issues... » more
Enables the user to map both GxP specific processes (CAPA, deviations, complaints etc.) and general processes... » more