Library | Case Study | An Innovative Approach to Glossary Management
Background
A client of ours, a large pharmaceutical company, requested our support in implementing a new industry standard document management system to replace their ageing system.
As part of this change, they tasked us with exploring how we could use new technology to resolve the issue of glossary management.
The client had hundreds of global and thousands of local Standard Operating Procedures (SOPs) and each of these SOPs had a section within it where glossary terms were listed and defined.
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The Problem
1. Subjective Approach
Which terms should and should not be defined in the glossary section was dependant on the decisions of the Authors. Some defined the most basic terms (approve, system etc) whilst others neglected to define core terms (SUSAR, SAE etc)
2. Inconsistent Definitions
Where the same glossary terms existed across multiple SOPs, the definitions often differed. This had resulted in an inspection finding
3. No Revision Process
No formal mechanism existed for an end user who might notice a missing glossary term or an incorrect definition to make a request for this to be added or amended
Finding a Solution
Firstly, we explored the technical capabilities of the new document management system being implemented. Though there was some basic functionality to be able to create glossary terms in a list, this was too limiting because:
1. The basic functionality did not allow for duplicate terms to be rejected
2. The limited number of users of the new system (see point 3 below) could not see the terms referenced in a document easily, they had to navigate via many clicks through to a metadata screen to see the linked terms
3. Most end users of the SOPs would not be interacting directly with the new document management system due to high license costs and training burden to access the system. Rather, they would be accessing the documents through a “portal” where the terms would not be visible
4. Terms could only have a single named owner. This would present issues in a large organisation, as people changed roles and joined/left the company
5. There was no request process for updating definitions of terms, one would simply need to find who the owner was (see point 4 above) and reach out to them via email
The Solution (Summary)
People
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Created a new responsible "role" of "Glossary Term Manager"
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Made department heads responsible for assigning people to this new role
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Created and provided training for this role
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Monitored how well people performed in this new role tweaking training accordingly
Process
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Developed and implemented a glossary term migration strategy for existing terms in SOPs
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Implemented a process for glossary term ownership based on most common use within SOPs
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Implemented a process for glossary term requests and approvals
Systems
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Migrated existing glossary terms from SOPs into a database
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Developed and released a new glossary request form linked to the database
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Created a glossary "pop-up" sidebar to allow in SOP (i.e. at point of use) glossary visualisation using highlighting and hover-over techniques
The Solution (Detailed)
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We extracted all glossary terms from the global documents into a large database, logging the SOP number where used and the Departments that owned the document (Clinical, Safety, Regulatory etc)
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We asked each department to identify one or more “glossary term managers” who would be responsible for the lifecycle management of glossary terms that would now be owned by Departments and not individuals within their SOPs
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We reviewed all the extracted glossary terms to find an owning department:
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Where the term was only used in SOPs owned by one department, that department now became the “owning department” of the term
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Where the term was used across multiple departments’ SOPs, we worked with the glossary term managers to agree on the best owning department
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We reviewed all the extracted glossary terms to find inconsistent definitions. For all of these, the new glossary term manager of the newly identified owning department was responsible for reconciling and providing us with the agreed definition
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We created a request form within the database that allows end users to make various requests:
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Updates to definitions of existing terms | approved by Glossary term manager of the owning department of the term
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Creation of a new terms | approved by glossary term manager of the department within which the requester sits (and approved new terms are owned by that department)
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Linking of terms to SOPs | approved by Author of the SOP
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Unlinking of terms to SOPs | approved by Author of the SOP
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Withdrawal of a term (so nobody can use it in future e.g. where company wants to restrict a certain terminology…IEC instead of IRB etc) | aproved by glossary term manager of the owning department of the term. SOP authors notified if the term will be withdrawn and therefore unlinked from their SOPs
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​​We logged change requests against each SOP requesting the author to remove the entire glossary section from their document in the next revision. We also updated the SOP template to remove this section to avoid new documents creating the same issue
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We worked with the developers of the “portal” through which the SOPs would be accessed by end users to develop an API that:
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Upon loading of an SOP, queries the database we built to see which glossary terms have been linked to that SOP
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Loads that list of used terms into a sidebar in the portal
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Finds uses of that term in the SOP and highlights (overlaid) each use directly on the SOP
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When a user clicks on the highlighted word, skips to that term in the sidebar to provide the definition, in addition to a link that the user can click to submit a request to update the definition
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As with all solutions, we closely monitored how well the solution was working and made small changes (e.g. to training materials) as needed​
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Note: images are AI generated and for illustration purposes only, as the solutions we produce for clients are their intellectual property and cannot be shown on our site
