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| Structured Product Label Creation and Management | |||||||
| SPL tool is an easy-to-use, content authoring application. Authoring is as simple as auto uploading the word document directly into | |||||||
| the application without the need for cut and paste operations from a source document. | |||||||
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Tool easily manages to create Labels in Structured Product Labeling as defined by USFDA. | ||||||
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The complex content structures, including tables, images, lists, and nested sub sections, are easily created by the tool. | ||||||
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Ability to execute generation at the Client or Server level giving great flexibility in resource utilization. | ||||||
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Has built-in feature for PLR and can generate SPL with or without PLR. | ||||||
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Every SPL output is validated by the tool against ELIPS Guidelines as mandated by USFDA. | ||||||
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Available as a service for label conversion based on the word or PDF file provided. | ||||||
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Multiple Users can work simultaneously on different products and prepare the final validated SPL/PLR xml files. | ||||||
Latest SPL Version 4 Compatibility for Drug Listing |
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| Structured Product Labeling (SPL) is a standard that will be used for the exchange of Drug Establishment Registration and Drug | |||||||
| Listing information. Drug Listing & Establishment Registration and Drug Listing information will be sent in electronic format (xml) | |||||||
| based on "SPL implementation Guide for FDA Drug Est. Regr. and Drug Listing V 1.0". | |||||||
| Fully Implemented Physician Labeling Rule (PLR) | |||||||
| Highlights can be uploaded from the word document directly or they can easily be entered for each section manually through |
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| easy-to-use user interface. | |||||||
| Complete validation SPL/PLR xml according to USFDA rules and guidelines. SPL / PLR Services Model. | |||||||
| 1 | Clients can provide the FPI (Full Prescribing Information) data in Word or PDF format. | ||||||
| 2 | DE (Data Element) information can easily be provided in our pre-defined word template. | ||||||
| 3 | PLR highlights can also be provided in word or PDF format. | ||||||
| 4 | Images can be provided as image files in jpeg format. | ||||||
| 5 | Drug listing data can be provided in our pre-defined template format. | ||||||
| Label conversion is done as per standard operating procedure defined, in secured and controlled environment. Our technical | |||||||
| staff has sufficient experience (more than 300 label conversions) to handle any type of SPL. | |||||||
| Submitting SPL to USFDA | |||||||
| Completely validated SPL/PLR is provided to the customer which can be directly sent to the USFDA. |
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| Note on SPL Validation | |||||||
| Submission of SPL is validated by USFDA according to Electronic Labeling Information Processing System (ELIPS) validation |
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| and conformance rules. This validation includes three tiers. Failure of the first tier validation prevents SPL from loading |
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| into ELIPS. Failure of second tier validation causes the SPL data elements to be flagged for manual review during the |
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| labeling review process. SPL cannot be transmitted to NLM (National Library of Medicine) until Tier 2 problems are solved. |
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| Final tier involves a manual review of data elements in SPL. | |||||||