The FDA implementation of SPL has continued to grow in scope over the last four years. Having a moving target makes implementing a software solution difficult to manage and maintain. The service-based approach allows clients some insulation from schema and scope updates.

Intagras provides SPL management services using the SPL Portal and SPL Enabler applications. The combination of SPL specific software used by SPL experts provides for the highest quality deliverable in an efficient manner. The SPL Portal provides a valuable interface for clients and allows Intagras to become part of your regulatory team.

The web-enabled application “SPL Portal” provides clients with the following over a secure connection:

• Unlimited submission transfer (upload and download)
• Download of previous SPL submissions
• Submission process dashboard

NDC LABELER CODES

Intagras will work with your team to properly collect and structure the NDC Labeler Code data required for your submission.

ESTABLISHMENT REGISTRATIONS

We will work with your team to collect and properly structure the data required for your establishment registration submission.

Labeling Conversions

Intagras converts existing Microsoft Word labeling to the latest FDA XML standards without placing constraints on existing processes. All schema and guidance updates will be available to clients the first day the guidance is required. Updates will not require any software updates for the client. All modifications are centralized and therefore will not impact your process.
Intagras uses a proprietary tool (SPL Enabler) to convert Microsoft Word versions of package inserts into SPL format. As part of this process, Intagras manages your SPL label GUIDs based on the FDA guidance.

Product Data Element Identification

Intagras uses the document text when possible to identify and populate the Product Element Database (PED) with the required data element structure. When necessary, Intagras will meet with the client authors/experts to identify elements of the drug element and confirm assumptions.

Post Conversion Quality Assurance

Intagras performs the following quality checks against each and every conversion:

• XML validity
• Schema validity
• FDA compliance (based on the FDA implementation guide)
• Content comparison (original document comparison)
• Image compliance (jpg)
• Packaging compliance (based on the FDA implementation guide)

Package Insert Version Management

Intagras retains and versions all of the following:

• Original MS Word package insert
• Post conversion MS Word package insert
• SPL / XML rendition
• Images

SPL Package Insert Delivery Process

Intagras will provide you with all files and images for each package insert to ensure electronic acceptance by the FDA.
Intagras will deliver the following items with each conversion:

• Post conversion MS Word package insert
• SPL / XML rendition
• Associated .jpg images
• HTML drug element review page

Audit Trail

All modifications are captured by user name and date.