SPL Portal is a web-based application with a central
repository that allows pharmaceutical companies to
manage and create product labeling compliant with the
latest FDA electronic registration and listing regulations.
XML content is stored and versioned at the section level
within the SPL database. Associations are created between
products, establishments, and labelers allowing for
centralized updates. Updates made to contacts, addresses,
and establishment operations are automatically propagated
to all mapped products, allowing for the most up-to-date
information to be included with the next product listing.
SPL Portal downloads the full content of the National
Library of Medicine DailyMed site and the FDA SPL
Terminologies nightly. This feature ensures SPL
Portal users will have the most current data available
at their finger tips. Users can search the entire contents
of the National Library of Medicine DailyMed site in seconds.
SPL Portal sends daily notifications to users
notifying them when products have been listed or
when products have been updated on the National
Library of Medicine DailyMed website. This feature
allows SPL users to know immediately when product
labeling has been updated!
Multiple Delivery Models
SPL Portal can be hosted internally by your
organization or companies can subscribe to
the hosted Software-as-a-Service (SaaS) application.
The SaaS model provides immediate global access with
no software to purchase or install.
All modifications are captured by user name and date.
Additionally, SPL Portal captures content values before
and after an update. This feature provides the basis
for SPL Portal’s audit trail functionality.
SPL Portal provides robust statistics dashboard
that detail how many submissions an organization
has created by: date, submission type, labeling
type, and product.