Dossier Management

FEATURE: 2

• Software Solution Architecture
  • It is n-tier architecture with file server, database server, Application server and submission process server.
    • 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.
    • File Server: Could be Linux based or Windows based. Here all the files / content files reside. Application server interacts with this file server as and when required.
    • Database Server: Currently portable only to MS-SQL 2000.
    • 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 e-CTD format is done here.

FEATURE: 3

• User Interface Aspects
  • Web Browser based interface. Currently best viewed in IE 6.0 on Windows 98/XP/Professional clients.
  • Concurrent usage for the same Drug Product on different CTD sections.
  • Context Sensitive help available for the user.
  • Interlocking of processes for integrity and proper user messages.
  • Detail Log reporting for every process.
  • Multi-user system that allows simultaneous work on many products.

FEATURE: 4

• Steps and Process for using the Solution
  • Prepare content files converted into PDF with conversion criterion as specified in the guidelines.
    Define Submission Plan in the software solution for a given product, regulatory body and CTD specification version.
  • Once the Plan is defined, Users can attach relevant PDF files to the corresponding sections from M1-M5.
  • Once all files are attached, Submission Process to be executed.
  • User then preview the Submission and can make changes to the files attached if required. The output is in the form of final e-CTD protocol.
  • Once satisfied, user can “freeze” the submission and cut a CD for dispatch.

FEATURE: 5

• Bio-equivalence Information
  • If bio-equivalence data needs to be send, User should use another Client software provided with the base engine to generate study tagging files information in the prescribed format.
  • Software handles USFDA released STF version 1.0 specification to do it.
  • This is seamlessly integrated with the base XML format of the overall submission and the software guides the user in the whole process.

FEATURE: 6

• Verification Tools
  • Submission Verification Tool
    • Which will highlight possible problems in the submission protocol.
    • Specific checks at various levels also possible to highlight errors in the e-CTD submission.
  • Specification Verification Tool
    • This verifies the e-CTD submission w.r.t the validations required by the specifications.
    • All aspects of the generated XML file is verified.
  • SPL Verification Tool
    • This verifies the e-CTD submission w.r.t the validations required by the ELIPS 1.4 Specs (Jan 2006).
  • CD Verification Tool
    • Verifies the submission once copied on the CD.
    • Verifies MD5 Checksums of the files copied on the CD.

Note: System will not allow the user to “freeze” the submission if there are errors found by the above tool thus ensuring integrity of the output.

FEATURE: 7

• Software Solution Features
  • Software solution handles e-CTD ICH / US / EU defined submission protocol validations.
  • Software solution automatically manages submission versions.
  • Manages Submission lifecycle as per guidelines from ICH.
  • Dossiers can be created for regulatory authorities as well as for customers.
  • Output contains XML instance, directory structure and content files.
  • Tested for volumes with submissions having more than 10,000 dossier content files.
  • Flexible design enables quick releases to support new specifications.
  • Various tools for XML viewing, DTD viewing available.

FEATURE: 8

• Unique Features
  • Specification can be built-in for multiple countries.
  • Software design can cater to any country dossier indexes thereby enabling the user to use this software for overall submission management also.
  • Non-regulated countries like Srilanka, Russia and many more countries indexes can be incorporated.
  • Ability to send selected information to the customers using the same e-CTD format.
  • Software allows inheritance of one submission details of one product and customer to another submission of same product but different customer. Thus reducing mundane task of attaching content files every time for the same product thereby improving efficiency.