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by Emerson Welch  |  February 27, 2024

Successfully Managing Highly Regulated Content at Global Scale

Highly Regulated Content at Global Scale

Businesses operating in any industry understand the role content plays in driving growth and cementing a strong footprint within the market they serve. For those that operate in highly regulated industries however, such as pharmaceutical and life sciences organizations, they cannot afford to publish out of date content and worse, content that doesn’t adhere to legal regulation requirements that vary by country. Consequences could range from hefty fines to product recalls – even risk to human health – and severely impact the company’s reputation.

This is the first of a series of blogs that look at the core factors organizations in these industries must address to execute a successful content strategy: that their content is, or must be, highly regulated, highly automated, highly complex or highly compliant. We call these the “4 Highlies”.


Let’s dig deeper into how organizations manage their content operations in highly regulated industries where it’s critical they have the platform, ecosystem and workflow infrastructure to create and publish regulated content at scale.

I was fortunate to have recently attended the Digital Pharma Conference in London and engage directly with people across pharma and life sciences companies who play a direct role in creating and publishing business-critical content. Many attendees were there for one primary reason: to investigate technologies to support their dynamic, flexible and global content strategies. Fortunately, many of the content stakeholders I connected with have a clear understanding of the value of an omnichannel content strategy. But how do you get there?

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If you can’t COPE, your regulated content can’t scale globally

Does your organization have the content operations infrastructure in place to support your content teams’ ability to create regulator-approved documents once and publish simultaneously to multiple digital outputs and across multiple geographies? Omnichannel publishing using a structured content authoring strategy is crucial for highly regulated content and a manual process won’t support your organization’s ability to keep pace with changing regulation requirements for your content. And remember, regulation flows through content in the pre- and post-delivery process, from how labels are marked, to approved terminology that must be used.

With a centralized component content management system (CCMS), regulated content can be easily accessed and distributed across multiple channels such as web, mobile, social media, and print. Your organizations can feel confident that consistent messaging and branding is always put forth, and sits accurately within the regulations for each regional output. Additionally, regulated content can be customized to fit the specific requirements of each channel, ensuring that it meets the needs of the audience on each platform.

A standardized content approach supports your omnichannel strategy as it provides a single source of truth that ensures consistency and reduces non-conformity risks.


Unlocking the opportunity with structured content

I learned at the conference that many involved in the content creation and publishing process are in the infancy stage of adopting or even considering a structured approach to content processes.

Content creators have much more control when taking a structured, XML-based authoring approach. And with Quark Publishing Platform (QPP) NextGen and its Microsoft Word plugin, they can focus on imparting knowledge right across the content ecosystem without getting bogged down with technicalities because no technical skills or training are required. When authors need a specific piece of content, they can search for it easily using the tag to pull the most up-to-date, compliance-controlled content – particularly beneficial for organizations responsible for delivering highly regulated content at global scale. Structured content components dramatically improve author efficiency, reduce the risk of publishing outdated material, and directly support omnichannel publishing strategies. Authors can create a content module once that is simple to personalize, regionalize and deliver across print, web, mobile and additional digital outputs for optimal consumption.

Quark has a long history in delivering tools that help pharmaceutical and life sciences organizations modernize their content operations to support an omnichannel content strategy. Quark Publishing Platform NextGen automates all of the complex content management, regulatory and compliance processes so organizations can achieve their most important objectives – from digital transformation and customer satisfaction to regulatory compliance and revenue growth. Deep investments in AI enable enterprises to automate key areas of the content lifecycle journey: from accurate creation, collaboration, and assembly to the power of delivering personalized, compliance-controlled content and knowing how that content is consumed.

To learn more about Quark Publishing Platform NextGen, you can request a demo.

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