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| It is a web-based Electronic Dossier Management© System that automates and seamlessly manages your dossier |
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| compilation process. | |||||||||
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It is designed specifically for the management of complex Submission life cycles using the ICH eCTD standards. |
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| Including regional module 1 for ICH countries. (US, EU, CA …). | |||||||||
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It is available as an independent product and also seamlessly integrates with other products like DocsExecutive™ |
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| thereby providing an effective management of the entire regulatory document management lifecycle, from document |
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| creation all the way to regulatory submissions. |
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Manages submissions for non-ICH countries (Sri-lanka, Sudan…) with equal ease. | ||||||||
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Submission lifecycle management and consolidated submission reviews. | ||||||||
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Document templates with corresponding CTD sections and seamless bridge with DocsExecutive™ effectively reduces time |
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| taken for eCTD Collation. | |||||||||
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Dossier-mgmt© eCTD software is fully validated with a track record of over 350 eCTD submissions done successfully |
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| to EU, US countries. | |||||||||
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Product is constantly updated to meet latest Regulatory guidelines. | ||||||||
FEATURE: 1 |
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Currently supported Specifications | ||||||||
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Incorporates ICH eCTD specifications V 3.2.2 (DTD V 3.2) for M2-M5. | ||||||||
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Regional US specification version 1.3 (DTD V 2.01) for M1 modules. | ||||||||
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Regional EU specification version 1.3, 1.2.1, 1.1 (DTD V 1.3, 1.2.1 and 1.1 respectively) covering National, Centralised, | ||||||||
| MR, DC Procedures. | |||||||||
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Study Tagging Files (STF) specification version 2.6.1 (DTD V 2.2) | ||||||||
FEATURE: 2 |
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Software Solution Architecture | ||||||||
| It is n-tier architecture with file server, Application/Submission Server and Database Server. | |||||||||
| Process Servers. | |||||||||
| A. File Server: Could be Linux based or Windows based. Here all files / content files reside. Application server interacts with | |||||||||
| this file server as and when required. | |||||||||
| B. Application Server: Windows 2000/2003 web-based application with Clients using IE browser 6.0 and above. This server | |||||||||
| is used by multiple users to upload multiple dossier content files while working simultaneously on more than one products. | |||||||||
| C. Submission Process Server: Could be hosted on the same Application server or for larger volumes a separate Xeon | |||||||||
| based Windows Server Machine is suggested. All the core process of submission and formation of eCTD format is done here. | |||||||||
| D. Database Server: Currently portable with MS-SQL 2000/2005 and Oracle | |||||||||
| FEATURE: 3 | |||||||||
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User Interface Aspects | ||||||||
| Web Browser based interface. Currently best viewed in IE 6.0 and IE 7.0 on Windows 98/XP/Professional / Vista |
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Concurrent usage for the same Drug Product on different CTD sections. | ||||||||
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Context Sensitive help available for the user. | ||||||||
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Interlocking of processes for integrity and proper user messages. | ||||||||
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Detail Log reporting for every process. | ||||||||
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Multi-user system that allows simultaneous work on many products. | ||||||||
| FEATURE: 4 | |||||||||
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Study Information | ||||||||
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Additional module for managing BA/BE Data to be used for eCTD preparation. |
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Software handles USFDA released STF version 2.6.1 specification [DTD V 2.2] to do it. | ||||||||
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This is seamlessly integrated with the base XML format of the overall submission and the software guides the user in | ||||||||
| the whole process | |||||||||
FEATURE: 5 |
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Verification Tools | ||||||||
| A | Submission Verification Tool | ||||||||
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Integrated with the base engine, highlights possible problems in the submission. | ||||||||
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Specific checks at various levels also possible to highlight errors in the eCTD submission. | ||||||||
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Verifies the eCTD submission w. r. t the validations required by the specifications. | ||||||||
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All aspects of the generated XML file are verified. | ||||||||
| B | CD Verification Tool | ||||||||
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Verifies the submission once copied on the CD. | ||||||||
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Verifies MD5 Checksums of the files copied on the CD. | ||||||||