Labeling and SPL
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The labeling and promotion of medical devices, pharmaceuticals and biologics are tightly controlled by the various bodies that regulate these products throughout the world. The FDA, in particular, is very stringent in its labeling and promotion requirements. A large percentage of medical product recalls are related to labeling issues and cost manufacturers millions of dollars per year.
Life Sciences companies need to address initiatives and standards including Clinical Data Interchange Standardization Labeling (CDISC), Product Information Management (PIM) and Structured Product Labeling (SPL). As such, these companies spend a great deal of time managing product labeling documentation such as package inserts, summaries of characteristics, and core datasheets.
Since labeling relates to every aspect of a product, and embodies both important intellectual property and significant liability in case of error, the preparation of labeling content involves the participation of subject matter experts from many corporate divisions: pharmacology, medicine, manufacturing, marketing, legal and regulatory affairs. And of all submission documents, labeling is the most frequently updated.
Because labeling updates occur throughout the market life of a product, the same information is often duplicated in multiple documents, resulting in a vast collection of documents that are difficult to manage and keep synchronized. To do so is not a brief or inexpensive process.
Meanwhile the FDA and other health authorities are moving quickly to require electronic submission of labeling content in xml format. As a result, Life Sciences companies need to implement and validate new technologies and processes in the short-term to ensure compliance with the FDA’s SPL requirements and the EMEA’s PIM requirements, while simultaneously selecting strategic technologies to meet the long-term requirements for scalability, content re-use and operational efficiencies.
With such a multitude of considerations, a tightly controlled, efficient process for the creation and maintenance of labeling and promotional items is an excellent way to ensure compliance and avoid costly recalls.
Pilgrim Software helps Life Sciences companies to effectively and efficiently manage labeling requirements:
Pilgrim’s SPL global labeling solution* is designed for organizations to meet the SPL (Structured Product Labeling), PLR (Physician Labeling Rule), and PIM (Product Information Management) standards put forth by the FDA. Companies can use Pilgrim’s SPL to author, publish, review, and save SPL-compliant labels. Conversion of legacy labels created using Microsoft® Word is built into the system. Companies can:
• Categorize labels by Product, Country and Submission Type
• Create label templates
• Create labels based on an existing template
• Import XML labels
• Track and retrieve current, proposed and approved versions of a label
• Support for SetID and rootID Life Cycle Management
• Render in various formats (SPL XML, SPL XML with FDA standard Style sheet, Rich Text Format (RTF) for viewing in Microsoft Word Format, Portable Document Format (PDF)
• Track Document and Section Level Versions
• Revert to an existing version
• Create and manage Library Content
• Clone content from Library for use in multiple labels
*In partnership with Virtify
At any time a Life Sciences company must manage multiple versions of package inserts, labels and related documents. Every change to a document must be reviewed and approved internally, submitted and approved by the FDA and flawlessly move into production.
With Pilgrim’s SPL global labeling solution, companies can:
• Ensure compliance with SPL and PIM by generating agency-specific renditions for electronic submission
• Improve efficiency by reducing the time required to create, review, and approve and manage product labeling documents
• Eliminate redundancy by reusing documentation components in multiple labeling documents
• Increase productivity by replacing manual procedures with automated workflows and electronic approvals
• Disseminate information more effectively by publishing product documentation into various formats such as xml, pdf, or other formats for world-wide health authorities that do not support xml
• Get products to market faster by supporting electronic submission to health authorities in xml format
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