Geoff LeCain
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Articles
Recent activity by Geoff LeCain-
How do I create a draft from a previous version?
Answer: To select a previous draft, select the “Previous Version” radio button located at the top of the Content Editor. Then select which previous draft you want from the drop-down menu. The examp...
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Inactive Ingredient(s)
The “Inactive Ingredients” section allows users to define the inactive ingredient based on the FDA rules. Users should define the inactive ingredient and strength if required by FDA guidelines. T...
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Why doesn’t the “Section 17” link work at the bottom of the highlights section?
Answer: The FDA style sheet links the “17” in the “See 17 for PATIENT COUNSELING INFORMATION” text with the “Information for Patients Section” LOINC. If there are multiple sections associated to th...
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Product Characteristics
The “Characteristics” section allows users to define the physical characteristics of the manufactured product based on the FDA rules. Select a value from the predefined list of characteristic and ...
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Which LOINC code should be associated with 17.2 FDA-Approved Patient Labeling?
Answer: If you have a Patient Package Insert in your label it should have the SPL Patient Package Insert LOINC associated to it and it should be a base section (not a child section).
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Product Packaging
The “Packaging” section allows for one to many packaging configurations per product formulation. Nested packaging can be defined up to four levels and can be enabled by checking the appropriate num...
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How do I add the text, “and FDA Approved Patient Labeling” after See 17 for Patient Counseling Information?
Answer: This text is automatically added to the style sheet when you add the section and assign the LOINC – SPL Patient Package Insert.
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Route of Administration
The “Route of Admin.” section allows the user to define the way in which this manufactured product is administered. Use the New button to define more than one route.
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I can’t view the Intagras or FDA style sheet, what can I do so that I can preview my files?
Answer: You just need to make a few changes to your Internet Explorer browser. For IE 7 and IE 8, do the following: Click the "Tools" menu and select "Internet Options". Click the "Security" tab. ...
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Import SPL
The content of label information can also be imported into a product from: A previously created SPL zip file containing the label information in XML format and associated JPG images. Or from an e...