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by Emerson Welch  |  June 3, 2024

Streamlining Content Processes: A Blueprint for CMC Success Through Reuse and Automation

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In the world of Chemical Manufacturing and Controls (CMC), where precision and compliance are non-negotiable, mastering the art of content creation and distribution is paramount. Navigating through the complexities of crafting documents tailored for diverse channels while adhering to stringent regulatory standards often feels like an uphill battle.

In this blog post, we embark on a journey to unravel the complexities of CMC content management and control, shedding light on the role of content reuse and automation in streamlining processes. Join us to explore how such strategies can alleviate the burdens of manual content creation and pave the way for enhanced efficiency, consistency, and compliance in the realm of CMC.

Streamlining Content Processes

The Challenge: Multiplying CMC Documents, Multiplying Problems

Imagine having to write the same information, slightly tweaked for different audiences across numerous CMC documents and platforms. The resources poured into redundant tasks, coupled with the struggle to maintain on-time deliverables, pose significant risks of inaccuracies and discrepancies. Time, as they say, equates to money – an invaluable resource in industries where precision is imperative.

This challenge is particularly prevalent in highly regulated industries like pharmaceuticals, where outputs like Analytical Procedures (APs), Testing Specifications (TSs), Validation Reports (VRs), and Test Specification Reports (TSRs) are of critical importance to the entire drug lifecycle. Complexities in organizing, storing, and auditing content, particularly for these types of industries, can have severe repercussions.

These interconnected elements form the backbone of product testing, establishing evaluation criteria, precise procedures, and ensuring the quality of life-saving medications. However, managing these documents traditionally can raise concerns about version control, consistency, and compliance. By leveraging structured content authoring, organizations can consolidate multiple documents to effortlessly generate user-friendly reports like the TSRs, which combines AP, TS, and VR into a single, easily accessible PDF format.

The Solution: Content Automation Empowers Content Reuse

By creating structured content once and seamlessly applying updates across relevant documents, organizations can significantly reduce redundancy and streamline workflows. Pharmaceutical professionals, for instance, can focus on creating high-quality content, leveraging a single-source-of-truth Component Content Management System (CCMS), alleviating the need to start from scratch with each new document. This approach not only enhances efficiency but also ensures content is translated and localized in line with regulatory guidelines.

Creating content from pre-configured templates allows pharmaceutical content authors to quickly and effectively do their work. GxP documents are pre-populated and configured with security for industry and health authority compliance. Additionally, utilizing dynamic content property placeholders during authoring facilitates a build-once-use-many approach for continuous publishing.

There is also a rising shortage of skilled labor in this field as many employees who possess this knowledge retire. Employers need to prioritize the happiness of their author team, as well as their productivity levels, if they want their onboarding pipeline to remain strong. Generation Z and X are more direct in what they are looking for in job responsibilities and cutting and pasting won’t meet their expectations.

Publish Once, Streamline Everywhere with CMC Content Automation

When we talk about reusing content, we talk about the process of omnichannel publishing via content automation – also described as “create once, publish everywhere.” This process simplifies the management of your content and lets you disseminate content effortlessly across diverse platforms, channels, formats, and languages.

With the help of AI and automation, authors don’t even have to generate the first draft. By ingesting data and mapping the correct relationships, the first draft can be generated for you, including structuring and formatting any tables, lists, graphs, or images. This doesn’t remove the author from the process but rather replaces mundane tasks filled with higher-skilled review and edit responsibilities.

From a tactical level, once an analytical procedure is created, it is stored as an individual component. This allows test specifications to apply reusable analytical procedures – and their translations – to different substances while remaining compliant. Analytical procedures linked to test specifications are stored in an automatically generated folder and can even be kept in a “related documents” tab to keep all your relevant information and documentation in one place.

No more scattered content across various locations and formats. Leveraging automation tools like Quark Publishing Platform NextGen and ComplianceAuthor® AI streamlines the CMC content creation and distribution process. This centralized approach ensures content is always updated, accessible, and consistent across all channels, optimizing your content workflow.

Benefits of Content Reuse

The advantages of content reuse extend far beyond just efficiency gains:

  • Reduced Time, Cost, and Effort: Content reuse saves valuable resources, allowing teams to focus on strategic initiatives.

  • Enhanced Efficiency: Improved search and discoverability lead to faster time-to-market and streamlined translation/localization processes.

  • Compliance Confidence: Organize, store, and audit content within a single source-of-truth, ensuring compliance for complex, regulated environments with versioning and branching.

  • Maximized ROI: Achieve goals faster with efficient content management practices.

  • Improved Team Moral: Removing copying and pasting will improve job satisfaction, resulting in higher productivity and reduced turnover or skills gap in your department.

In conclusion, navigating the complexities of CMC content management doesn’t have to be an uphill battle. By embracing content reuse and automation strategies, pharmaceutical companies can streamline workflows, minimize errors, and ensure consistent compliance with regulations. This shift towards a data-driven, automated approach unlocks the future of CMC content management – one that is efficient, consistent, and empowers content creators to focus on strategic initiatives.

Streamlining Content Processes
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