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SPL Package Insert Conversion Process
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Document Scrubbing
The first step in the SPL conversion process is a document review and
modification to ensure conformance to our client’s formatting standard, use
of tables, and proper formation of lists. This step is performed to ensure
the highest level of conformance and mapping to SPL structures.
Data element identification and database population
Intagras uses the document text when possible to identify and populate the
Drug Element Database (DED) with each drug’s required data element structure.
When necessary Intagras will discuss with our client’s authors/experts to
identify elements of the drug element and confirm assumptions.
Word to SPL conversion (Drug Conversion Application)
Intagras uses a proprietary tool (SPL Enabler) to convert Microsoft Word
versions of package inserts into SPL format.
Post conversion quality assurance
Intagras
- XML validity
- Schema validity
- FDA compliance (based on the FDA implementation guide)
- Content comparison (original document comparison)
- Image compliance (jpg or gif)
- Packaging compliance (based on the FDA implementation guide)
Client
Our clients are provided the opportunity to perform additional quality
assurance checks to confirm the SPL document is acceptable.
Package Insert Version Management
Intagras retains and versions all of the following:
- Original MS Word package insert
- Post scrub MS Word package insert
- SPL / XML rendition
- Images
SPL Package Insert Delivery Process
Intagras provides our clients with all files and images for each package insert
to ensure electronic acceptance by the FDA.
Pre-Production FDA Test Submissions
Intagras works with our client’s labeling department to submit test SPL labels
to the FDA.
Call 813-226-1867 to schedule a free demonstration to our SaaS portal solution.
You may also e-mail for more information:
info@intagras.com
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