Structured Product Labeling Module

TAKE’s PharmaReady™ Structured Product Labeling (SPL) is an easy-to-use, web-based content authoring application. The solution facilitates the creation of the SPL documents such as content of labeling, product listing, establishment registration and NDC Labeler code request. PharmaReady™ SPL enables pharmaceutical, biologics, generics, animal health and over-the-counter types of sponsor companies to be compliant with SPL R4 requirement.

Product Highlights

• Fully implemented physician labeling rule
  • User-friendly interface with context sensitivity for simple and error free authoring and coding
  • Reference lookups are provided for highlights and drug listing data elements wherever appropriate
  • Built-in validation engine ensures 100% SPL-PLR compliance

• Content management, collaboration and granular authoring
  • Multi-user label authoring feature supports independent section authoring on a concurrent basis within a label
  • Users can collaborate and share information during review and approval processes using the notes feature
  • Review comments can be generated as printable reports
  • Role-based security is provided for editing, reviewing, approving and publishing the labeling content

• Life cycle management
  • Existing SPL labels can be imported and revisions can be made
  • Changes in the content are automatically tracked
  • Appropriate root ID is generated and ID for sections is also set
  • Automatic version control is provided

• Validation
  • Built-in validation which ensures tier 1 and tier 2 validation compliance by checking against the SPL business rules and schema

Why TAKE's Product

• Authoring is as simple as copying and pasting content from a source document into the editor
• Complex content structures such as tables, images, lists, and nested subsections, are easily created with state-of-the-art content handler components

• Legacy and prior versions of SPL documents can be easily migrated to the current SPL R4 standard