Managing Pharma-based content data is a monumental task for most companies in this industry.
However, the ability to recycle content across a broad range of regulations and requirements can make a substantial difference to a company’s bottom line.
Pharmaceutical companies are under intense time constraints to create and update product content.
The challenge is to do this as efficiently, cost-effectively, and accurately as possible.
The Content Condition
It’s an understatement to say Pharma companies produce an absolutely mind-boggling amount of content. When it comes to this content, compliance is mission critical.
The pharmaceutical industry has more regulations than any other industry related to its artwork, labeling, and other content.
Additionally, every country adds its own specific two cents to these regulations and requirements, further complicating the process.
As such, reusing that which has already been developed, vetted, and approved for release, makes the ultimate sense for such a content-burdened industry. This enables companies to better scale their content practices.
Why are brands looking for a Structured Content Management Solution?
Labeling and packaging requirements from regulatory bodies are ever increasing.
Product purpose and intended use need to be easily understood because lives depend on it. For example, MDR in EU has very specific requirements for medical devices.
Brands must therefore ensure their product content adheres to local and global standards, no matter the market or language. A “simple” label update is full of complexities. This process is further exacerbated when managed with manual processes.
Structured content is necessary because:
- Manual processes are cumbersome
- Changes to labeling and artwork are multi-faceted operations
- Tracking multiple documents and versions is difficult
- Global expansion and location regulations create significant complexities
- Inefficiencies belabor content processes
- Copy and pasting leads to errors and duplicate content
A structured content solution benefits brands by:
- Eliminating the use of multiple word documents for version control
- Tracking changes with audit trails
- Automating the reuse of content
- Mitigating risk in regulatory submission documents
- Ensuring visibility of changes and removing duplicate content with one-to-many relationship tracking
- Driving efficiencies with streamlined collection, approval, and distribution of content
- Managing and tracking local regulatory requirements and translations in a central system as your organization grows and expands
- Automating artwork updates for increased time savings, improved quality, minimization of manual processes, and reduced risk
The Esko Structured Content Management (SCM) Prescription
Esko’s Structured Content Management, a module of WebCenter, is the cure.
It allows companies to create, approve, translate, and transfer content automatically. It reduces risk by standardizing the content collation process, defining content ownership, promoting content reuse, and tracking changes for IFUs, leaflets, and other documents for submission to regulatory bodies.
Using SCM, pharmaceutical companies can update content faster with impact reports to assess and initiate change, establish a company-wide process to create and maintain structured content, and consolidate multiple content platforms into one source to improve version control.
Structured content can also be integrated with existing architecture to enhance the migration of data.
Thus, product content health is restored by the digitalization of the regulatory submission document format within a central system. Much of the content used within these documents can be reused across similar types of products with minimal changes if managed properly.
Variable content items are easier to manage, saving time, especially when circumstances such as multiple languages and regions are taken into account.
Preparing for Tomorrow
Harnessing Pharma content, organizing it, and saving it for reuse is how companies reap the benefit of efficiencies resulting from implementing structured content management.
The likelihood of enhanced accuracy in such a highly regulated industry is an added dividend paid to companies willing to employ digital solutions to manage their processes with state-of-the-art solutions.
Interested in learning more about how your company can leverage Structured Content Management? Watch the webinar recording, Structured Content Is Coming to Pharma: Steps to Take Today to Prepare for Tomorrow!
You’ll learn how to streamline content processes and reduce risk by standardizing and centralizing the content collation process.
Structured content and data management in combination with cloud technologies will enable pharmaceutical companies to:
- Construct regulatory filings concurrently
- Submit filings simultaneously to multiple health authorities
- Allow collaboration between agencies
- Simplify information requests from health authorities
This webinar focuses on actions Pharma companies can take today to prepare for using structured content management in the future.
Watch this webinar to explore:
- The benefits of structured content
- How to identify and communicate business drivers in your organization
- What content analysis is and why it is important
- When to use strategic consulting services
- How to identify software necessary to implement structured content