|
|
| Home > Regulatory
Software > Document Management > InSight Overview |
 |
 |
Liquent InSight® Manager: Overview
Overview > Features & Benefits > Technical
Specification
As global regulatory authorities unify their submission structures through new and emerging
standards like the CTD, eCTD, EVMPD, SPL, and PIM, the need for effective regulatory product
management in the life sciences industry has become critical. Life sciences companies need to
be able to analyze, understand, maintain, and revisit often hundreds of product registration
details, reuse the same documents and data and maintain product licensing in dozens of different
markets, identify obsolete documents caused by amendments and variations to regulations, and
much more.
To help life sciences companies meet this challenge, Liquent has created Liquent InSight® Manager.
It supports the entire regulatory product management lifecycle, from the early planning of registration
targets through to product retirement, and is invaluable for regulatory planning, product detail
management, dossier creation, dossier management, project planning, and more.
Using Liquent InSight Manager, you can:
- Collect, manage, and analyze detailed product information to help you make better decisions
faster
- Centrally collect, manage, and track worldwide product authorizations and registrations
- Track the regulatory compliance status of source documents throughout a dossier’s lifecycle
- Reduce the resources needed and time taken to plan, locate, and assemble regulatory content
- Improve your time to market by using consistent, reliable processes for gathering document
information, tracking submission status, and verifying official documents
- Decrease compliance risk by allowing users to verify the external approval status of a submission
or source document, while providing integrated support for 21 CFR part 11 regulations
- Increase global coordination and collaboration between interdepartmental groups and affiliates
by sharing a single, central resource with a unified Web interface
- Enhance your company’s efficiency by effectively managing the entire product submission
process from conception to retirement
|
