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What is it:
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SPL (Structured Product Labeling) is a FDA community XML standard to facilitate reliable communicating of drug information reliably among various groups needing access such as the FDA, hospitals, prescribing organization, doctors, and the general public. The US Food & Drug Administration (FDA) CDER division has provided guidance for all human pharmaceutical labeling data to be transmitted with SPL since late 2005. Other FDA divisions such as CBER (Biologics), CDRH (Medical Devices), CVM (Veterinary Medicine), and OND (Over-the-Counter) are expected to follow suit starting in 2008. SPL is both an HL7- and ANSI-approved standard, Structured Product Labeling ANSI/HL7 SPL, R1.0-2004.
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Capability:
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Conversion of data & documents to XML - SPL
- XML data conforms to FDA SPL requirements -- guaranteed
- High volume bulk conversion
- Single-order conversions through web interface
- Support for organizations developing internal capabilities
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| DCL Experience:
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- On the SPL Working Group
-- Created most SPL Working Group data samples
- Successful pilots with Fortune 100 pharmaceutical companies.
- 20+ years in conversion business
- Authored chapter on ‘Legacy Data Conversion’ in
Columbia Guide to Digital Publishing
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Differentiators:
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- In-depth experience with SPL
- Capability to implement content reuse program to identify reusable text and burst documents into modules for process efficiency improvements.
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Languages:
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Experience with most foreign languages including Latin based and double-byte characters.
- Experience with Unicode.
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Partnerships:
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- Arbortext (XML Authoring)
- i4i (Authoring Software)
- Documentum (Content Management)
- Intrasphere (Consulting)
- First Consulting Group (Consulting)
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Process:
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Three-phase process consisting of:
- Project Engineering (creation of specification, hand tagged sample, pilot conversion, and QA checklist)
- Production Conversion
- Data load into repository
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For More Info:
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Data Conversion Laboratory, Inc.
http://www.dclab.com
(505) 275-2223
e-mail SPL@dclab.com
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Other References:
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- FDA SPL Resources Page
http://www.fda.gov/oc/datacouncil/spl.html
- CDER Requirements for PLR Prescribing Information
http://www.fda.gov/cder/regulatory/physLabel/default.htm
- The Real Story on XML at
http://www.dclab.com/realxml.asp
- 7½ Secrets for Managing XML Migration at
http://www.dclab.com/7.5secrets.asp
- The Future of Labeling - Pharmaceutical Executive
http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=146595
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