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Report Level Publishing including Life Cycle Management!

Often a series of regulatory documents will be prepared in stages and/or by different groups. RLPmanager was designed to allow the easy and accurate creation of documents and studies in a separate environment from the resulting use of the documents themselves, such as being used for various sections of an eCTD. Hyperlinking and even Studies with associated Study Tagging Files (STF) can be included. Entire document sets or subsets can be published electronically or on paper.

RLPmanager is also integrated with, but does not require, eCTDmanager. When used with eCTDmanager, a very easy to use drag-and-drop feature is available that allows the addition of documents individually or in sets to be added to the eCTD with one simple "drag and drop" operation.

RLPmanager – User benefits

The benefits of RLPmanager include:

• Improved document quality
• Easy integration with eCTDmanager. Documents (with or without hyperlinks and studies are added to the eCTD with one simple "drag and drop" operation. Fast access to documents for everyone has access to the electronic dossier
• Shorter approval times
• Reduced time to market Less quantity of paper and lower logistical overhead

Lifecycle Management of Documents

RLPmanager's visual structure editor allows you to compile reports and documents step-by-step. Structural elements can be easily added, edited and deleted. Documents can be scanned, copied, moved or imported by 'drag-and-drop' from the file system or from most DMS’. Hyperlinks and comments can be set at any time during compilation. Document and study attributes can be set prior to eCTD building.

RLPmanager has been designed with an architecture allowing multiple users access to multiple submissions simultaneously. Parts of the dossier can be compiled at different global sites. A sophisticated replication mechanism has been implemented especially for using RLPmanager in globally distributed workgroups. This reduces network traffic and delay. RLPmanager can be easily integrated into document management systems such as

• EMC Documentum Content Manager™
• FCG First Doc™, FCG First Point™
• IBM Score™
• Microsoft Sharepoint™
• OpenText Livelink™
• QUMAS DocCompliance™
• and others 

Application Benefits

Your main advantages for using RLPmanager are:

• process efficiency
• cost reduction and
• faster time to market

Related EXTEDO Applications

• eCTDmanager™ – Electronic and Paper Publishing of medicinal product and medical device approval applications
• eCTDmanager view™ – A submission viewer tightly integrated with eCTDmanager and its Submission Life Cycle database
• eCTDmanager review™ – A submission reviewer tightly integrated with eCTDmanager with additional annotation functions
• DMSconnect™ – A configurable standardized connector for leading Document Management Systems
• miniDMS™ – A basic layer for version control and LC management of regulated documents
• DOCmanager™ - A management component to maintain master submissions and associated regional submissions
• PcVmanager™ – Electronic management and reporting of adverse events based on the E2B standard
• PLmanager™ – Native authoring and management of PIM and SPL labeling documents
• CTmanager™ – Electronic management of Clinical Trial Applications
• DRAmanager™ – Integrated control and tracking of life sciences products and associated regulatory affairs processes
• DOCvalidator™ – Automated Document Format Compliance check for Word and PDF documents
• EURS is Yours™ – The Agency eCTD Review and Validation System

Documentum is a trademark of Documentum, a division of EMC Corporation; DocCompliance is a trademark of QUMAS; Livelink is a trademark of OpenText. All other trademarks, trade names and service marks are the properties of their respective owners.