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ALiCE for Labeling - US SPL Edition

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Improving Efficiency and Accuracy

The FDA’s SPL initiative, designed to play a vital role in improving patient safety in the United States by providing timely, accurate drug product information to health care providers, patients and the public continues to rollout at a rapid pace.

Today the requirement for electronic registration and listing in SPL extends to all Labeler, Manufacturers and Distributors of Human Prescription, Over-the-counter (OTC), Veterinary, Biologic, Active Ingredient, Homeopathic and Medical Device Products.

ALiCE for Labeling brings a comprehensive set of content management capabilities to support greater efficiency and accuracy in the creation and management of compliant SPL submissions. It can also provide direct integration with broader organizational processes that leverage product and labeling information.

A Modular Approach

Integrated with i4i’s market leading A4L Professional, ALiCE is modular in nature and highly configurable, with its capabilities delivered through an intuitive web browser interface.

ALiCE for Labeling extends the authoring platform to bring key capabilities including document management, submission tracking, collaboration, label management, and content re-use and repurposing.

The Web Client allows easy access to workflow processes and management functions.

 

Getting Started

The out-of-the box base module provides a fast and cost-effective entry point to the organization and management of in-process and submission-ready SPL documents:

  • 21CFR11 Document Management (Role-based Security/Permissions, Document/Submission Versioning, Electronic Signatures, Audit Trail)
  • Dashboards for process management
  • Comprehensive & Configurable Document Lifecycle (Draft, Review, Approve, Effective)
  • Cross document Content Re-use (LCR, ER, Listing) & Change Impact Analysis
  • Source Document Relationships & Automatic Word Renditions
  • Integrated Messaging and Notifications
  • Automated FDA Resource Updating and Submission Validation

Roles of users and document status are configured to support existing internal processes and rules. Documents are checked in and out, automatically versioned, and related to other documents through a simple web browser interface. Metadata (properties) such as brand name, dosage forms, and active ingredients are automatically extracted for easy access and workflow. The effective version of documents is always visible and its complete history available at the click of a mouse.

Registration, Listing and Content of Labeling activities can be done in parallel by different users/departments, supported by up-to-the-minute controlled vocabulary and UNII codes. All documents are then brought together and thoroughly validated for compliant submission publishing.

Throughout their lifecycles, Word renditions of SPLs can be automatically produced. Integrated messaging is used to support an efficient review and approval process.

Process dashboards support the management of the who, what, where, when and why of your content, capturing key metrics throughout its full lifecycle.


Collaboration

The Collaboration Dashboard provides a single point of management for the parallel review process. Using Word’s familiar Track Changes feature, multiple copies of a document, with editing and commenting, can be merged into a single view for final review and approval.

A4L's integrated messaging system aids efficient process flow and completion.


Variant Management

The management of multiple variants/branches of a document is required as new indications, formulations, and adverse events trigger changes to content. This can be extremely challenging. Knowing the status of each document and bringing the correct information together is critical.

The Variant Dashboard provides a comprehensive set of functions that let you initiate a "branch" (a parallel version of a product label), substantiate it using a Change Request document, and track and merge branches accurately, thus ensuring each new submission is fully compliant.


SPL Repurposing

Leveraging the power of XML, SPL information can be easily repurposed to support the accurate production of key related documents such as packaging, marketing documentation, Medication Guides, and Patient Information.

Departments responsible for related documents can easily identify the currently effective version of labeling information and ensure the content of all documents remains consistent.

Content Repurposing

 

ALiCE for Labeling

A suite of web services manages versions and variants in A4L.

ALiCE web services

ALiCE Web Services