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Software > Product Registration Management > IMR: Overview |
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Liquent InSight® Manager for Registrations: Features & Benefits
Overview > Features & Benefits > Technical
Specification
Built upon Liquent’s unparalleled experience and regulatory knowledge base, InSight Manager for Registrations (IMR) is designed to ensure
that your products are on track for market approval, and properly maintained over their marketing lifetime.
IMR tracks products and marketing authorizations in order to ensure a common global understanding of regulatory approval status while reducing
CMC and regulatory research effort.
Features include:
- Technical Features
- Rich, easy-to-use Web interface
- Zero footprint desktop install. No plug-ins, ActiveX controls, or Java applets required
- Part of an integrated portal suite that includes InSight Manager for Assemblies, InSight Foundation, and InSight Publisher
- Uses best-of-breed Web architecture standards for a global work environment
- Based on industry standards like Oracle, Internet Explorer, LDAP, and J2EE
- Open Data Model allows for easy use of 3rd Party Reporting tools like Crystal Reports and Business Objects
- Robust and Highly Flexible Data Model
- Complete Global Registration Activity is maintained in a Robust and Flexible Data Model
- The model Supports business processes for Mutual Recognition, Centralised, Decentralised as well as National Procedures
- The Data hierarchy is modeled after the eCTD structure
- Data fields are included to support EudraVigilance Medicinal Product Dictionary (EVMPD) compliancy
- The Data Model supports the inclusion of client customized data fields
- Product Detail maintenance allows for complete regulatory planning and history tracking of:
- Country Specific Details
- Drug Substances
- Raw Materials
- Excipients
- Manufacturers and Suppliers
- Packaging
- Labeling
- Indicatio
- Flexible and Customizable GUI Interface
- A Highly customizable graphic interface facilitates a personal user experience by enabling features such as:
- Client defined attribute and tab labels
- Client defined field positioning
- Inclusion of client customized data fields
- Localization of country, region, language, and character sets
- Extensive client defined dropdowns fields assure data consistency throughout the system
- Intuitive Tab Metaphor results in logical grouping of entity data
- Coordination and Communication Features
- Task Creation and Maintenance
- Create and maintain task work lists from any entity
- Monitor the progress of tasks such as PSUR preparation, affiliate approval and lifecycle maintenance tasks
- Perform commitment tracking through use of the task functionality
- Rules Based Notification Functionality enables users to set e-mail reminders and notifications when a new entity is created or modified.
- Examples of E-mail Reminders that can be pre-set:
- Notify and remind affiliates that specific tasks are due
- Notify responsible parties of up-coming renewal, annual report, or expiration dates
- Communicate a change in regulatory or task status
- Notify your organization of regulatory approvals and changes that have taken place
- Set reminders in order to assure commitment compliance
- DMS Integration
- Create a Link directly to a DMS object to enable users quick access to important documentation
- Link Approval Letters to Registrations
- Link Regulatory correspondence to help with commitment tracking
- Link to Labels to allow for quick and easy access of country and packing specific label information
- Targeted Reporting
- Compare manufacturing details across countries and registrations
- Query on the lifecycle of registration changes (variations, amendments, annual reporting, etc.)
- Facilitate the Project Management of regulatory actions by identifying projected vs. actual dates
- Monitor market approvals against target dates to ensure that marketing launches (and projected revenue) are on schedule
- Maintaining planned vs. actual dates supports efforts for improving future planning
- Save often used queries for quick and easy access to standard result sets
- Standard Impact Analysis queries are available to assist in feasibility and planning of manufacturing changes
- All query results can be exported to excel for further analysis and use
- Additional Features
- Fast searching on product, and application data
- Integration with existing security and directory systems using industry standard protocols such as LDAP
- Configured by metafiles for control of attribute labels, status labels, field positioning, and other user interface features
- Localizable by country, region, language, and character set
- Includes the ability to set security at a Product Family and Country level
- Self-auditing database designed for 21 CFR Part 11 compliance
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