Maintaining compliance in content for life science enterprises requires combining data storage, regulatory requirements, and industry best practices. Omnichannel content publishing for paper-based writing, reviewing, and approving content such as test analysis documents and clinical research reports is not sustainable at scale without a ‘single source-of-truth’ and a modular, componentized content strategy at the core
Traditionally, life science organizations — especially those in large pharma, generics, BioTech, medical devices and clinical research organizations — had to keep their content stored across many different places, formats, and channels. This approach was costly and created pitfalls for productivity, efficiency losses and the use of unverified, out-of-date content.
For example, industries in life science sectors face the unique challenges of creating, managing, and publishing test specifications and analytical procedures for pharmaceutical ingredients. Life science sectors are under constant scrutiny and need to meet the highest standards for security, compliance and consistency.
Without an effective omnichannel content publishing tool, life science companies risk losing compliance and may wind up providing substandard care to the people their products are engineered to help or worse still, endangering patient safety with a direct risk to their health.
Delivering the best possible timeline for product-to-market requires navigating many more hurdles than other industries. For starters, agencies like the Food and Drug Administration (FDA) and European Medicines Agency (EMA) require that life sciences companies adhere to strict, localized regulations.
There’s a lot on the line for life sciences companies. If medicines are not produced in compliance with these governing bodies, the life science company risks extreme repercussions from the health agency.
The life sciences industry has much more demanding technical documentation authoring processes. These processes are complex due to different markets, production variations, pharmaceutical label structure guidelines and regulatory requirements, which can vary significantly across the world and are liable for change at any time.
Quark automates these time-intensive activities within one software application called Quark Publishing Platform (QPP) NextGen. A single content repository houses critical asset components — or building blocks — like properties, pictures, graphics, notes, and text snippets. Content automation helps streamline the assembly of these components, optimizing their reuse and speeding up the publishing process, reducing costly human error.
Quark XML Author, the built-in Microsoft Word plugin, can be used to create highly technical content components easily, using the familiar Word interface. It auto-generates XML metadata for each component which makes searching for content to be reused fast and effective. If changes are made to the content block, any other place they are used automatically updates, meaning only compliance-controlled content is being used in what could be thousands of different content types. For users preferring not to use Microsoft Word, Quark Author is the browser-based option which works in tandem to provide freedom of choice for subject-matter experts to work in the most productive way.
QPP NextGen lets you quickly create, publish and manage changes to regulation-heavy labels across all output channels.
Because it syncs your content updates everywhere, you can reuse structured content without worrying about regulatory blowback. A safer and more secure publishing cycle decreases operational costs and helps you comply with FDA, EMA and any other regulatory agency labeling or standard operating procedure (SOP) requirements for medical-related products.
QPP NextGen has applications for life science industries including, BioTech, clinical research organizations, generics, healthcare, large pharma, medical devices & equipment, pharmaceuticals and more, improving operational efficiency for sensitive information like Structured Product Labeling (SPL), and Electronic Medical Records (EMRs).
There are four key benefits to life sciences organizations adopting a modular and omnichannel publishing strategy: