KnowledgeNET

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KnowledgeNET (Document Management):

The challenge for businesses these days are to provide the right information that leads to effective knowledge: Knowledge that can be used to make better decisions. Increasingly today, organizations are looking to foster internal collaboration and knowledge sharing amongst employees, reduce information overload, capture & replicate best practices, leverage existing investments and maximize their use in a collaborative knowledge environment, exploit multiple and disparate knowledge resources. Digitech-Solutions makes this fact a reality providing its clients with the Knowledge Management Solution that integrates multiple knowledge management functions on a single platform.

KnowledgeNET includes:

  • Document Management
    Store, organize, access, share, search, control, and manage all your enterprise documents quickly, conveniently, and securely.
  • Dossier Preview
    Publish Your Dossier Online in Secure way
  • eCommon Technical Document (eCTD) Submission
    Submission for Regulatory Affairs
  • Standard Operating Procedures (SOP) Management
    Create, manage, review, approve and retrieve SOPs in a secure environment
  • Structured Product Labeling (SPL)
    Management & Submission for Regulatory Affairs
  • Business Process Management (BPM)
    Process/Project tracking solution

Document Management

A comprehensive solution which enables companies to Store, organize, access, share, search, control, manage and reuse the vital corporate knowledge contained in enterprise documents- letters, reports, manuals, invoices, photographs, engineering drawings, illustrations, diagrams, audio, video and other sources of information.

Key Features:

  • Data Storage Capabilities
  • Security
  • Collaboration
  • Search
  • Web Based Integration

Standard Operating Procedure (SOP) Management

The solution helps in creation and distribution of SOPs in compliance with regulatory authorities. The system helps is change management, review reminders, recall tracking and version control. Global and department wise segregation helps in better management and monitoring. Definition of process points makes distribution monitoring and control easier while alternative to attach SOP to user groups helps in training retraining management.

Key Features:

  • Compliance
  • Security
  • Collaboration
  • Search
  • Web Based Integration

eCTD Submission

Submissions to regulatory (US FDA, UK MCA, etc.) authorities will have to be done in electronic format very soon. To manage electronic CTD (Common Technical Document) and their submissions we have a powerful, feature-packed eCTD Submission solution that does virtually everything from store to organize to share to manage your enterprise quickly, efficiently, reliably and above all, securely. eCTD solution helps to create, update, store and publish the complete set of documents and manage, compile, review, register and archive submissions.

Dossier Preview

Dossier Preview solution helps companies to publish the dossiers on the Internet for prospective customers to study.

Key Features:

  • Create, Store, Update, Publish, set permissions etc. for the dossier
  • Create users and set privileges
  • Secure Central repository
  • Secured publishing of the document where the user cannot copy, save, print, etc.
  • User can only view the document

Structured Product Labeling (SPL)

Pharmaceutical and Biotechnology companies are required by the regulatory agencies (FDA) to compile and maintain large and complex collections of product information. Product information follows a continuous cycle of creation, approval and dissemination. The solution enables companies to convert new and existing labeling contents to XML and submit both the narrative labeling content and the drug listing information to the regulatory agencies (FDA).

Business Process Management (BPM)

A tool to monitor the progress of development or submission project, where activities to achieve final objective are clearly defined and assigned to individual users against time line. Vital information/documentation against each activity can be uploaded and shared among the users. Feedback/Comments against each activity can be shared. Automatic management alerts for delayed and incomplete activities.