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Liquent InSight® Manager: Features & Benefits
Overview > Features & Benefits > Technical
Specification
Features
Registration planning and tracking
Whether you are planning the launch of a new product, need to track product registrations,
or are looking to update your existing registrations, the Liquent InSight Manager Registration
Planning and Tracking function provides you with all the critical information and powerful capabilities
you need.
Through a single, central resource, you can easily maintain marketing authorization details
for all current and planned products, including manufacturing and labeling details, commitments,
licensing details, and registration status. You can ensure your products are on track for market
approval and are properly maintained over their marketing lifetime.
Liquent InSight Manager enables you to:
- Monitor market approvals against target dates to ensure that marketing launches and projected
revenue are on schedule.
- Provide and track product or submission-specific correspondence
- Identify maintenance tasks associated with a product, submission, or correspondence
- Perform impact analysis of proposed or actual product detail changes to determine the effect
on products and notification requirements
- Automatically identify necessary submissions when product changes warrant action
- Maintain compliance as product, market, and regulatory conditions change
Step-by-step guidance
Liquent InSight Manager takes you step-by-step through the process of
updating your registrations. For every product that is registered or is pending registration,
you can confidently answer questions like:
- Which licenses are due for renewal?
- What are the ramifications of changing a supplier?
- What information must be submitted in response to a new regulation or change?
- How can I find information quickly to respond to a specific agency enquiry?
- Have all the requirements been satisfied to bring a product to market?
- Are my company’s processes compliant today and will they still be in the future?
- Does everyone in the company know what is registered and where?
- What information has been provided to affiliates regarding plans or status?
Invaluable communication tools
Liquent InSight Manager includes a range of invaluable communication tools
to help you effectively manage and track your product registrations. These include:
- A task assignment capability to help you plan and track important status dates and responsibilities
- Robust e-mail notification features that send reminders of approaching due dates or notify
you that everything is progressing on schedule
- The ability to link both internal and external correspondence to your registration activities
and maintain an accurate record of ongoing actions and communications
- An approval wizard that guides you through the process of updating your registration activities,
marking them as complete and then creating or updating the registration license itself
Submission planning and tracking
Liquent InSight Manager comes with automated project planning tools to
help ensure you deliver your regulatory submissions on time. The project management function
in Liquent InSight Manager automates much of the project plan for you, so you can focus
on tracking progress against plan, instead of worrying about the validity of the plan itself.
Liquent InSight Manager also simplifies and speeds up the dossier creation and review
process and enables you to track the external approval status of all documents.
The numerous submission planning and tracking features in Liquent InSight Manager include:
- A status awareness feature that works across a dossier and uses icons to indicate missing
content, missing versions, and superseded documents
- The ability to create automated dossiers with planned document locations that synchronize
with, and can receive updates from, your Document Management System (DMS)
- The ability to efficiently create and review a list of source documents required for a collection
of assembled regulatory content
- Reports for standard, productivity-related metrics and the ability to track actual versus
projected milestones
- The ability to easily monitor key progress indicators in order to determine the submission
status at any time
- The ability to easily export views, reports, and results to Microsoft Project and Excel
- A logical area to store all regulatory correspondence within business objectives, submission
sequences, or project tasks
Registered document analysis
Even after market approval, life science companies still have a critical need to
keep track of the status of their documents and regulatory submissions. Documents relating to
the original submission and approval often need to be shared between multiple regions, repurposed
for regional use, or replaced, appended, or deleted in subsequent submissions via the eCTD. When
this happens, tracking which versions of the various source documents available were used in
the submission(s), as well as the regulatory approval status, can be highly labor intensive.
However, Liquent InSight Manager enables you to create and keep track of multiple submissions
in the post-approval environment, so you can benefit from considerable time and cost savings.
Using Liquent InSight Manager, you can:
- Store and categorize all dossier and submission information relating to products, drug applications,
business objectives, and submission sequences in a logical area
- Make smarter decisions about document usage by understanding the historical composition of
the sequences that make up a submission set
- Accurately determine the regulatory relevance of a source document to see if it should be
used to initiate an update
- Quickly locate specific documents and answer agency enquiries with confidence
- Identify which versions of which source documents are associated with registrations in each
region
- Maintain compliance while reusing as many leaf documents as possible when making submissions
in multiple markets
- Minimize the amount of manual data entry required for leaf attributes and associated XML
files by having them automatically populated by the system
- Fully reuse all dossiers as templates or as the basis of new submissions
- Quickly import and export document collections and dossiers as virtual documents or XML
Easy-to-use Web interface
Liquent InSight Manager has a rich, easy-to-use Web interface that has
a zero footprint desktop install and requires no plug-ins, ActiveX controls, or Java applets.
It also contains a self-auditing database that has been specially designed for 21 CFR Part 11
compliance, as well as audit trail configurable security features and validation scripts.
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