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 can help companies to convert their existing SPL R3 files to SPL R4 and get compliant even before the June 2009 FDA mandate.

Following is the validated process that is followed within PharmaReady SPL Center to convert source documents into SPL-compliant XML files.

Label Conversion Services (SPL-PLR)

Step 1: Collect Label Content

Label Content has the following components:

• Narrative Content (Full Prescribing Information): Clients can provide this content in Word, PDF, Native PDF or any other custom format.
• Highlights (For PLR only): Clients can provide this content in Word, PDF, Native PDF or any other custom format.
• Image content: Molecular images, company logos, etc., can be provided as image files (jpeg, bmp, tiff or any other custom format).
• Drug Listing Metadata: Can be provided using our pre-defined easy-to use template which captures all the required compound data information. Please do send us an email or call us to get a sample drug listing metadata template.
• 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. Please do send us an email or call us to get a sample Highlights Data Element template.

A secure and validated environment is provided to our customers for label content communication.

Step 2: Convert Label to SPL-PLR

Your label goes through the following conversion assembly line:

For PLR labels, the following additional steps are needed:

• 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

Every one of the above processes is well established and recorded. The label conversion services are performed in a secure and validated environment. Our technical team involves specific user roles responsible for the processes mentioned above. Our content conversion experts have extensive domain expertise in Regulatory Labeling Requirements and are trained in providing in-depth quality assurance.

We provide detailed Conversion Reports and Conversion Worksheets to our customers enabling complete visibility to our conversion activities. Please do send us an email or call us to get a sample Conversion report and Conversion Worksheet.

Step 3: Deliver Label in SPL

The following are provided as part of our deliverable package to our customer for every label conversion assignment:

 

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, 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).

PharmaReady SPL product has built-in validation which ensures tier 1 and tier 2 validation compliance by checking against the SPL business rules and schema.

According to the most recent mandate from FDA, as of June 1, 2009 the following three types of communications required for Human health (Prescription, OTC), Animal health, Biologics and Vaccines organizations have to be in SPL – R4 standard:

These communications are currently submitted in paper form using Form FDA 2656, Form FDA 2657 and Form FDA 2658. With the new mandate sponsors are required to replace these forms with an electronic submission using the SPL – R4 format.

PharmaReady SPL Center provides both technology and conversion services for the following sponsor companies to be compliant with SPL R4 requirement.

The PharmaReady SPL team can help companies to convert their existing SPL R3 files to SPL R4 and get compliant even before the June 2009 FDA mandate.

PharmaReady SPL Center has extensive experience of converting and creating thousands of labeling XML files fully compliant with SPL guidelines and accepted by FDA.