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docuBridge

LORENZ’s docuBridge is the state of the art submission management tool recognized by both life sciences companies and reviewing agencies throughout the world.  With docuBridge it becomes easier to manage your submissions and balance between regulatory requirements and technical possibilities.

Click here for the brochure of docuBridge.

 

LORENZ's docuBridge has the following features:


•    Submission Management by design:

 

LORENZ docuBridge was designed from the ground up as a submission management system, not merely an eCTD publishing tool. As a result, customers can leverage the existing systems and processes for newly evolving e-submission standards. LORENZ always focuses on process over format when designing products.

 


•    International in Scope:

 

LORENZ docuBridge is a tried and tested system in over twenty countries with many thousands of e-submissions to its credit. As a result, LORENZ is well aware of the various interpretations of the ICH guidelines, as well as varying validation rules that each country and/or region devises for itself. This knowledge is reflected in product design and functionality.

 

 

•    Document Management System:

 

LORENZ docuBridge can link up to any number of different Document Management Systems (DMS) in parallel. Currently, LORENZ docuBridge has drag-and-drop connectors to EMC Documentum, MasterControl, Microsoft Sharepoint, NextDocs, OpenText Livelink, Qumas DocCompliance and SAP ERP. Connections can be made to further Document Management Systems via LORENZ’ proprietary regDoc software.
In addition, LORENZ docuBridge operates relatively independently from DMS upgrades. This minimizes efforts on either side when upgrading a full DMS or when upgrading LORENZ docuBridge.
For those companies without a corporate-wide DMS, LORENZ docuBridge bundles a 21 CFR Part 11 compliant DMS that allows all types of companies to work in compliance.

 

 

•    Advanced Lifecycle management:

 

LORENZ docuBridge sports the most advanced Life Cycle Management engine with version V. The solution is based on LORENZ' own Real Time Document & Submission Processing Framework (What's this?). Among other benefits, it allows LORENZ to use its own methodology to manage the lifecycle. This reduces the risk of noncompliance as standards change. It also adds functionality to an otherwise more limited lifecycle management concept as defined by the eCTD. LORENZ docuBridge’s lifecycle management concept can thus be applied across standards, significantly increasing the value of the work put into compiling e-submissions for later re-use.

 

 

•    Performance and Scalability:

 

LORENZ docuBridge V takes another giant step in terms of performance and scalability. Workloads can be distributed across multiple servers, allowing tasks to be paused and resumed or even redirected which is particularly important if faced with hardware failure. Additionally, a new submission access methodology increases performance dramatically when in lifecycle mode.
In laboratory environments, without distributing tasks in parallel to multiple servers, LORENZ has already achieved publishing speeds of over 15,000 pages per minute. This makes LORENZ docuBridge V the fastest publishing system in its class.

 

 

•    Paper and Electronic Compliance:

 

Paper is still a requirement in most countries. Customers do not need to create different submissions for their paper and electronic processes. Through the use of the real-time framework, it is easy to utilize the same submission for the paper as well as the electronic output. Overlay information regulates the different views a user may have, but no changes are made to the content of the submission itself.

 

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