Navitas Life Sciences pharmaREADY SPL module is a web-based structured product labeling and management tool specifically designed for Life Science organizations where ease of installation, ease of use, regulatory compliance, and affordability are the primary business drivers.. It meets current regulatory standards while also allowing for best practice processes to be employed.
pharmaREADY SPL Module is available as an independent product or is easily tightly integrated with other pharmaREADY products including pharmaREADY DMS and pharmaREADY eCTD.
pharmaREADY SPL is an end-to-end web-based SPL system providing:
- Narrative Content (Full Prescribing Information): Clients can copy content from Word, PDF, Native PDF or any other custom format.
- Highlights (For PLR only): Clients can copy content from Word, PDF, Native PDF or any other custom format.
- Image content: Molecular images, company logos, etc., can be provided as image files (jpeg).
- Drug Listing Metadata: Can be provided using our pre-defined easy-to use template which captures all the required compound data information. Please send us an email or call us to get a sample drug listing metadata template. {Note: Either make the blue text clickable to get to an email page or when the user hovers, the email address and phone numbers are shown}
- Highlights Data Elements (For PLR only): Can be provided using our pre-defined easy-to-use template which captures all the required Highlights data information. Author Full Prescribing Information and Highlights Text.
- FPI and Highlights Narrative Text Analysis Identify the Data Elements to code Coding Highlights Data Elements (HLDE).
- XML Preview.
- QC of HLDE.
- Generate SPL-PLR compliant XML.
- FDA-ready SPL package as required by FDA which can be submitted directly to FDA. This package contains the converted XML file, associated molecular images and other images.
- Drug Listing Data Element Form providing the drug listing data elements and the codes.
- Highlights Data Element Form providing the Highlights data elements and the codes.
Label Creation and Management
pharmaREADY SPL 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.
pharmaREADY SPL has comprehensive workflow features supporting multi-user authoring, collaborative review, approve, and publish.
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. The user can generates the appropriate root ID for each individual section once changes are complete. 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).
The pharmaREADY SPL product has built-in validation which ensures tier 1 validation compliance by checking against the SPL business rules and schema. The tier 2 validation can be done through the FDA Pragmatic validator tool.
SPL conversion Services
pharmaREADY SPL Center has extensive experience of converting and creating thousands of labeling XML files fully compliant with SPL guidelines and accepted by FDA.
The pharmaREADY SPL team has helped companies convert their existing SPL R3 files to SPL R4 and get compliant even before the June 2009 FDA mandate.
