23rd German Quality Management Association

Date 20-21.9.2018

Venue: Maritim Hotel in Bonn

In the exhibition area arivis will inform you about the advantages of the 21 CFR Part 11 compliant Raw data archiving with BM-Watcher and BM-windream.

Lots of analytical equipment generates raw data, which is in a complex context: files with measured data, many of which have paths linking to the associated methods and sequences. Data already archived can often only be reprocessed after laborious recreation procedures. BM-windream is the first Windows® integrated 21 CFR Part 11 compliant data management system with Acess control, Audit trails, File versions, Electronic Signature, Lifecycle, Automated indexing of all data an integrated electronic long term archive.

New BM-Watcher enables you 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 automatically created. 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.

About the conference

The German Quality Management Association (GQMA) is Germany’s largest, and Europe’s second largest, association dedicated to quality management in the chemical and pharmaceutical industries. Why we chose the term "Good Research Practice" you can read at the end of this text.

By our own periodicals, seminar presentations, and annual meetings (usually held in September each year), we try to achieve a high degree of information and advanced training for the members. Our working groups promote an exchange of views, engage in the evaluation of current topics in the relevant spheres of activity, and represent the GQMA point of view in publications. Contacts with other QA societies and organizations serves the cooperation for conferences and in the evaluation of guidelines in the different GxP areas.

Visit us at GQMA:

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More about BM-Watcher!

Raw data archiving made easy with BM-Watcher

BioMedion has completed the development of a new version of the BM-Watcher. 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 automatically created. 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.

The monitoring strategy of the BM-Watcher can be configured in different ways. One possibility is the immediate transfer of the data to the archive, but alternatively the transfer can also take place after a certain time or after the creation of a certain file.

In the latest version, the BM-Watcher can now also be configured and monitored via a central server. The configuration is done with the help of modules that provide functionality such as the determination of metadata. These modules are configured using XML files. All configuration changes are traceable in a system audit trail.

The configuration server supports device monitoring via a status page. The current status is visible at a glance; systems in error state are distinguished from correctly closed systems.

 

Phone
+49 30 3384395-01

arivis BM-Windream

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 ... » more

arivis BM-Flow

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



 

 

Duration: 
Thursday, 2018, September 20 to Friday, 2018, September 21