Creating leaflets for pharmaceutical products poses significant challenges. Most leaflets are managed in Word format to comply with the preferences of regulatory agencies. However, Word is not a viable database when it comes to managing a mountain of pharma content. It’s difficult to search through hundreds or even thousands of pages to make a single update.
The future of leaflets is electronic. Legislation driven by multiple agencies will soon require e-leaflets, providing the same product information as paper leaflets, but via a scannable barcode or short link. In today’s wired world, e-leaflets are just a click away, making product information more accessible to doctors and patients. However, this convenience will be anything but convenient for pharma companies. Mobile apps serve part of the story: PharmaLedger, the joint venture between 27 major pharmaceutical companies, has a great application all but ready to go. This connects the patient directly with the leaflet simply by, for example, scanning a QR code with a phone. But the big challenge now is, how do you manage the content electronically in the first place, ensuring your leaflets are correct, both on paper and digitally? And what happens when you need to make changes? How do you know the right version of the content is sent to and updated correctly in the PharmaLedger app, for example? Currently, the leaflet content process is accomplished manually by copying and pasting, which is risky and error prone. There has to be a better way, and there is.
Esko is a key technology partner to support the creation and modification of e-leaflets. WebCenter, our workflow management solution, enables you to streamline your e-leaflet process using the structured content management (SCM) module. Let’s look at how Esko’s digital solution helps your process every step of the way.
Why Use Structured Content Management (SCM) for E-Leaflets?
Structured content is the process of planning, developing, and connecting content that can be reused across outputs. It is a more efficient process resulting in better quality and compliance. It coordinates the regulatory efforts of a company globally, including affiliates and partners, within a single system tightly integrated with label and packaging departments. SCM helps you ensure your content is right first time, every time.
With WebCenter from Esko, you are able to create, collaborate, approve, localize, and output content directly in the software. Reduce risk by standardizing the content authoring process, defining content ownership, promoting reuse, and tracking changes for leaflets, IFUs, and other documents for submission to regulatory bodies. Why duplicate content when you can reuse it?
Additional Features & Benefits of SCM
One of the time-consuming aspects of editing a leaflet is ensuring those edits are made across the board. With SCM, you make one edit and then apply that edit across all necessary e-leaflets. This also allows you to easily conduct impact analyses and provide traceability.
Reusing content saves the time and associated costs of recreating every new leaflet. It also shortens the time to submission by working with previously vetted content. This is useful for future products as well; if you start with a certain percentage of already approved content, then any associated e-leaflets can be approved faster. Create once and approve once!
We all know that clarity is just as important as speed. The more understandable and consistent your content is, the faster regulatory agencies can evaluate your submission, and the faster the process becomes. However, clarity doesn’t just help regulatory agencies, it also helps your team focus more on implementing changes.
The Takeaway
Complying with the myriad of regulations imposed on the pharma industry is, at best, a daunting endeavor. Today’s successful pharma companies cannot afford to be mired in old processes and approaches such as copying and pasting. Structured content management, as offered by Esko’s WebCenter, is essential for creating compliant e-leaflets efficiently, quickly, and accurately.
