Pharmaceutical Labeling and the Promise of SCA, Part One

Pharmaceutical labeling content requires compliance, accuracy, collaboration between departments and stakeholders, and often translation. When most of the process happens through disparate platforms, it becomes time-consuming and costly for life sciences organizations.

Structured component authoring (SCA) has the potential to transform pharmaceutical content authoring in a way that’s never been seen before. To dive deeper into the opportunities of SCA, we’re exploring how utilizing a single solution can increase efficiency for the complex labeling process even though the life sciences industry has resisted — until now.

In part one of our Pharmaceutical Labeling and the Promise of SCA series, we’ll take a closer look at unique challenges in pharmaceutical labeling, examine why the industry has yet to fully utilize SCA and set the stage for how collaborating with a Life-Sciences-focused solution partner could give organizations a boost in the resource-heavy labeling process.

Summarizing the complexities of pharmaceutical labeling

When considering what developing a new pharmaceutical product from discovery through market entails, it’s complex and includes teams of experts and many other technical resources. Labeling is a critical step in the approval process for new medicinal products that involve specific guidance for different document types, a range of local health authority regulations, and varied submission formatting requirements.

Additionally, labeling documents contain information about how the medicinal product will be prescribed and administered to patients. This information is often updated during the lifecycle of a product and requires that every update be reviewed by the internal company experts as well as by the health authorities, which issue the approval. Because content must be authored, managed and then submitted to health authorities, pharmaceutical companies employ a considerable amount of resources to manage this content.

In short: authoring content for labeling documents is a complex process that requires multiple tools and processes in place to ensure that information at every stage is accurately updated.

Why SCA has been slow-to-adoption for the Life Sciences industry

As a concept, SCA is not entirely new for the life sciences, but there has been hesitation to adopt a platform. Though SCA has been an aspiration for the industry with the move to a structured component authoring platform, it hasn’t become a concrete option yet because many of the available solutions and tools have not enabled successful adoption.

For those involved in the pharmaceutical labeling process, there seems to be less risk in using familiar tools — even if it is not as efficient as it could be. For example, many companies use Microsoft Word and a combination of other programs to handle different stages of the process. Word is used for the actual authoring, and then another platform manages the review or storage of the document — there are a lot of tools in place to manage the process, and for authors, it feels comfortable, proven, and established.

However, the life sciences industry is aware that there is a better way to go about the labeling content process. As the buzz around component authoring increases, there are pioneers in the industry that are talking about the options and looking for ways to start, whether it’s starting small or big — and switching to SCA is a perfect solution for more efficient authoring.

Benefits of SCA for a complicated labeling process

As cost increases continue to trend, businesses in the life sciences must find ways to optimize resource-consuming processes like labeling. Many organizations are searching for a way to have a more efficient process with increased visibility into where content is in the authoring process so that they can operate with more speed.

Another factor influencing solution adoption is that many life sciences organizations are not limited to one country or region. For example, if a company wants to make a product or therapy available globally, they need to ensure that product information is disseminated and authored accurately across all countries where the company operates and is looking to make that product available, as well as approved by the country’s specific health authority.

Approved content reuse is another appealing attribute of a modern SCA solution. With a product like Docuvera and its component-based authoring rights, it’s possible to reuse content because it’s already an authoring component, and it can be tracked. A project can be outputted in the platform, then outputted into the various formats that customers need, whether a Word document, PDF or HTML.

Docuvera also offers functionality to tag specific components with properties — comparable to metadata that describes what a component is about — so you can add text to the product information or other elements to describe the content. Tagging and reuse is helpful because if there is specific content around adverse reactions, users can clearly see where it’s used throughout all of the labeling projects that are in Docuvera, and updates can be made easily.

Is implementation the real roadblock for SCA and the Life Sciences?

From efficient authoring, reviewing, tracking and auditing to the possibilities of approved content reuse, as well as seamlessly translating or exporting into various formats, it’s easy to recognize the benefits of component authoring for labeling. But, adopting a new tool, especially for a globally-situated life sciences company, can be risky.

For any solution, successful implementation requires gaining organizational buy-in, change management, training, potential downtime, and increased IT responsibilities, to name a few concerns. In part two of this series, we’ll dive deeper into how Docuvera approaches the SCA implementation process with a strategy designed specifically for successful solution adoption in a Life Sciences organization.

Docuvera: SCA designed for the Life Sciences industry

At Docuvera, we get it. Labeling documentation must be efficiently developed and accurate to meet drug development timelines and avoid compliance violations. With our end-to-end SCA solution, life sciences organizations can reduce labeling content production times, ensure alignment to compliant content, and create faster time-to-market for regulatory submissions.

Connect today to learn more about how our modern SCA solution can optimize your labeling process.