SPL Product
TAKE's SPL solution is built on the trusted PharmaReady Submission Management Framework. PharmaReady is an industry-proven solution, suitable for all sizes of pharmaceutical organizations that are required to create SPL-PLR compliant labeling submissions with built-in version control, workflow and security features. You can purchase PharmaReady as a stand-alone product, integrated with DMS, or integrated with eCTD and DMS.
One Stop Label Creation And Management
TAKE's SPL solution is an easy-to-use, web-based content authoring application. Authoring is as simple as copying and pasting content from a source document into the editor. The complex content structures, including tables, images, lists, and nested subsections, are easily created with state-of-the-art content handler components.
TAKE's SPL solution has comprehensive workflow features supporting multi-user authoring, collaborative review, approve, publish and archival processes.
Fully Implemented Physician Labeling Rule
Our user-friendly interface with context sensitivity helps make highlights authoring and coding simple and error free. Reference lookups are provided for highlights and drug listing data elements wherever appropriate. The built-in validation engine ensures 100% SPL-PLR compliance.
Content Management, Collaboration, And Granular Authoring
The 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. The 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
Through the use of Life Cycle Management, existing SPL labels can be imported and revisions can be made. This application automatically tracks the changes in the content and generates the appropriate root ID as well as sets the ID for sections. Automatic version control is provided.
Validation
The FDA requires a label to pass both tier 1 and tier 2 validations and to be 100% SPL compliant. Failure of first-tier validation prevents SPL from loading into ELIPS (Electronic Labeling Information Processing System used by FDA). Failure of second-tier validation causes the SPL data elements to be flagged for manual review during the labeling review process. It prevents the SPL from being transmitted to NLM (National Library of Medicine).
TAKE's SPL solution has built-in validation which ensures tier 1 and tier 2 validation compliance by checking against the SPL business rules and schema. Your TAKE Solutions-generated SPL is guaranteed to be accepted by FDA.
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