In the pharmaceutical industry, the high volume of documentation necessitates precise and accessible analysis, control, and tracking. This can be accomplished with intelligent metadata. Metadata provides human-readable summaries and machine-readable information about your documents.
Document metadata can come from three major sources: the document itself, a document management system, or externally. Document-derived metadata contains information about the contents of the document. A prominent example of this type of metadata is IDMP data. On the other hand, system-generated metadata does not describe the contents of the document. Instead, system-generated metadata is attributed by the system to describe the management and history of the document. Identification numbers and modification dates are examples of system-generated metadata. Externally applied metadata contains information that the user associates with a document or information applied to a document by an outside system. Externally applied metadata can track document relationships across content management systems. For example, this metadata can be used to link CCDS and jurisdiction documents.
All three of these forms of metadata contribute to analysis, control, and tracking of documents.
Analysing with metadata
Document management systems can use document-derived metadata to display information about the content of documents. This enables you to see what your documents are about without even opening them.
With this metadata, comparison between drug labels is simple. IDMP tags, for example, can contain information about drug indications and contraindications. For multiple drug labels per product, such as for multiple jurisdictions, this metadata can be easily compared to ensure consistency between labels. This eliminates the laborious and repetitive process of reading the contents of each document for comparison.
Documents can also be filtered or grouped based on their content, such as by product or active ingredient, using similar metadata analysis.
Controlling with metadata
Document management systems process system-generated metadata to make information about the management and history of the document readily available. This information can include the document creation date and the last user to modify the document. Externally applied metadata can also provide document workflow statuses. This metadata can control or restrict the actions that can be performed with a document based on its status. For example, deleting, editing, or signing a document can be restricted to specific workflow statuses or only to the author of a document.
Document-derived metadata can also be used to restrict the actions that can be performed on a document. Document type metadata can be used to define unique workflows for different documents. Product line or active ingredient metadata can be used to restrict editing and deleting permissions for sensitive products.
Tracking with metadata
Externally applied metadata can track relationships between documents across systems, such as between Company Core Data Sheets and jurisdiction documents. When a change is requested for a Company Core Data Sheet, changes must be applied to the labels for the various jurisdictions. External metadata can correlate this request in one database to the status of each of the jurisdiction documents in another to ensure that all necessary changes are made.
The i4i solution
All of these implementations of metadata can be found in A4L Enterprise, i4i’s complete document authoring and management solution. A4L Enterprise is comprised of A4L and ALiCE, our authoring tool and document management system, respectively. With A4L, authoring starts with metadata-rich templates. From there, ALiCE pulls information from your documents to allow for easy manual curating or automated filtering. Information about the history and workflow of each document travels with it in its metadata, and external metadata enables comprehensive integration and tracking of documents between systems.
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