Jahres Archiv: 2012

eCTD Module 1

eCTD Module 1

Module 1
Administrative Information and Prescribing Information

The name of the folder for module 1 should be m1.

This module contains administrative information that is unique for each region. Regional guidance will provide the specific instructions on how to provide the administrative forms and detailed prescribing information.

Country (national or EU / USA / Japan)
  • Application number centralised application Number or MRP procedure number
  • Calibri;”>Agency-name picklist value in the most recent EU m1 eCTD specification
  • Submission type picklist value in the most recent EU m1 eCTD specification
  • Procedure type picklist value in the most recent EU m1 eCTD specification
  • Invented-name trade name
  • INN The International non-Proprietary name for the drug substance
  • Sequence The sequence number here must match the sequence number in the folder structure
  • Related-sequence
  • Submission-description This element is used to describe this particular eCTD sequence

Country In the centralised procedure, there should only be one envelope with the entry ‘emea’. For MRP/DCP, each country in the procedure needs to have a separate envelope entry. Common must not be used as a country identifier in the envelope.
Application number The application number should be the centralised procedure/application number (EMEA/H/C/…), MRP/DCP procedure number (e.g. SE/H/1234…) or other national application or licence number as required by NCAs. Multiple entries are possible. The full application number including the regulatory activity identifier should be used if known.

Applicant Entries for ‘applicant’ should be consistent for all eCTDs from any single applicant (legal entity), as they define where eCTDs are stored in internal systems. Consistency of spelling is also relevant over time to allocate the eCTD correctly.
Agency-name Self explanatory, from picklist in the most recent EU m1 eCTD specification. Assure that Country and Agency name will be consistent.
ATC If unknown at the time of submission, the entry can say ‘to be confirmed’.
Submission type From picklist, see m1 specification for further details.
Procedure type From picklist, see m1 specification for further details.
Invented-name The trade name/invented name for the medicinal product covered by the application. If the eCTD covers multiple strengths or dosage forms, this entry does not need to describe the complete name, a simple entry, for example, ‘Wonderdrug’ will suffice.
INN The International non-Proprietary name for the drug substance.
Sequence The sequence number here must match the sequence number in the folder structure.
Related-sequence For a description and example of how to use the ‘related sequence’ entry
2012-04-12Permalink

Searchtechnology xPlore

Searchtechnology xPlore

Additional to my study papers a little summary of the next generation full text engine xPlore.

XPlore was released October 2010 for Documentum 6.5 SP2 / 6.5 SP3 / 6.6 and worked in the Dual Mode with the FAST engine. Since Documentum 6.7 and CenterStage 1.1 only xPlore search is available.

FAST vs. xPlore Interface

Result by xPlore engine. This shot was taken from CenterStage version 1.2

Search Result with FAST engine. This screenshot was taken from the TaskSpace 6.6 envirnment.
Filtertypes. Screenshot taken from CenterStage 1.2

Benefit

  • The main benefit is the complete new indexing services based on Lucene of the Apache Software Foundation. Lucene works on the Documentum xDB (XML Database) und using the XQuery Language.
  • xPlore provides native support for ACLs. Unauthorized documents are not collected.  FAST engine collects all result document and the ContentServer filter the results.

Exam question

Search features: Search ranking compared.

Webtop Taskspace CenterStage
procentual no ranking up to three bullets

 

addition links

Jeetu is Chief Marketing Officer and Chief Strategy Officer for the EMC Information Intelligence Group.
http://blog.pateljeetu.com/2012/02/15/searching-for-a-better-answer-xplore-your-way-through-the-enterprise/

EMC xPlore Overview

EMC xPlore Questions & Answers (as of summer 2010)

2012-04-10Permalink

Documentum Records Manager

Documentum Records Manager

Records Manager

RM extends the core Documentum content management capabilities by adding features and functionality.
RM is split into discrete modules. Customers can shoose RM modules that meets their unique requirements.

  • Retention Policy Management: Using RPS as the underlying engine, RM enables users to create, manage, and use retention policies.
  • Security and Access Control: Enhances the security model by providing non-cumulative permissions and the ability to associate permissions with object types. Enhances access control by requiring membership of one or all of a set of designated groups.
  • File Plans: This is an automated control mechanism for permanent system-wide record classification. It specifies how to name, classify, organize, and retain/dispose records.
  • Containment Policies: Specify rules for using a folder hierarchy or a file plan in terms of how it can grow and what actions are permitted within portions of the hierarchy.
  • Naming Policies: Configure naming conventions and enforce them through validation and dynamic name generation.
  • Retention policies: Determines the length of time a document based on operational, legal, regulatory, fiscal or internal requirements.

 Core Content Services

  • library services
    • check-in /check-out
    • Versioning
    • Basic renditioning
    • does not support inport/export capabilities
  • workflow services
  • lifecycle services
  • XML services
    • XML Applications
    • XML Store
    • XML Transformation services
    • XQuery (W3C standard query language for querying collections of XML data. XQuery can be combined with DQL and full-text searches.)
  • Federated Search Services
  • Content Transformation Services
    • Document Transformation Services (DTS)
      Renditions of MS Office or HTML files.
    • Advanced Document Transformation Services (ADTS)
      Renditions of additional formats: Project, Visio, AutoCAD. Creates bookmarks and advanced options for controlling PDF output formats
    • XML Transformation Services (XTS)
      Transform XML wo web formats, mobile formats, PDF, RTF or PostScript
    • Media Transformation Services (MTS)
      create metadata of photos, images and PowerPoint slides
    • Audio/Video Transformation Services
      Extension of the MTS
  • Content Intelligence Services
    Content Intelligence Services analyze the content using linguistic algorithms. CIS creates content related terms, keyword and attributs (metadate).The Services can classify the content into categories according to predefined rules.
  • Content Delivery Platform
    •  Interactive Delivery Services (IDS) formerly Site Caching Services
      IDS and IDSx provide static and dynamic content to a wilde range of network environments. IDS and IDSx supports AJAX (Web2.0) technology between the source and the target. User-generated content can be stored directly into the repository.
    • Interactive Delivery Services Accelerated (IDSx) formerly Site Deployment Services
      IDSx extends the capabilities of IDS.

      • publishing o content to multiple geographic locations by providing target to target reokication (server farms / independent dadacenters)
      • images and flash videos delivered with full metadata using WAN transfer
      • the IDSx transfer protocol utilizes existing network infrastructures and monitors all transfers using Adaptive Rate Control (VOIP, web, email)
2012-03-28Permalink