Product labels, data sheets and regulatory submission packs
Operational Effectiveness, Digital Transformation
Improved regulatory communication and timely submissions in the required formats using a streamlined structured authoring tool in Microsoft Word.
Achieved a standard and efficient centralized documentation process across the US, South America, UK/IRE and the EU.
Eliminated human errors and improved regulatory compliance across global operations, using one centralized platform.
This significant player in the agricultural science and technology sector plays a crucial role in enhancing global food security. They empower farmers worldwide to maximize the use of essential resources such as seeds and pesticides. Operating in nearly 100 countries, they revolutionize agriculture through cutting-edge research and innovative crop solutions, transforming how crops are grown.
Agricultural product labels are subject to heavy regulation by country-specific agencies, particularly in the US, South America, UK/IRE, and the EU. To obtain and maintain product registration, this organization must produce supporting documentation that demonstrates safety for workers, the environment, crops, and consumers across over 100 countries and multiple market regulators.
Additionally, labels must comply with strictly regulated artwork standards to gain approval for use, further emphasizing the importance of compliance. Due to the nature of the industry, there are several regulatory updates per year, making it essential for the company to keep up with the changes.
Consequently, the organization sought a structured authoring solution to streamline their authoring and publishing workflow, ensuring control and traceability throughout the content lifecycle. The system needed to be efficient in delivering accurate and timely documentation, as any errors or delays in the publishing process can have severe consequences.
The streamlined approach not only improved efficiency and compliance but also gained recognition from regulators for showcasing Quark’s potential to transform the regulatory landscape. Market regulators realized the benefits of a similar XML-based approach for their own internal processes.
The solution was the Quark Publishing Platform (QPP), a modern cloud-based structured authoring and dynamic publishing platform. QPP offers a comprehensive solution to meet the organization’s requirements for product labeling documents and regulatory submission packs. By leveraging QPP, the organization has gained access to enhanced capabilities and features that facilitates their lifecycle management processes.
One of the key advantages of the centralized platform is its ability to improve audit trails by streamlining the process of tracking and changing content. The end-to-end solution offers full control over global content, while also providing clear and comprehensive reports reflecting every change made. This heightens transparency and traceability significantly contributing to better compliance with regulatory requirements, minimizing the risk of errors and omissions, and ultimately improving the organization’s overall efficiency.
A significant component of the platform was Quark XML Author, a Microsoft Word plug-in. This plug-in allows authors worldwide to adopt the flexible Quark Smart Content XML schema without the need to learn an entirely new system.
Furthermore, the platform was configured with nine powerful starter templates, featuring reliable component content storage and assembly capabilities managed from the central CCMS repository. This standardized and consistent approach empowers authors to effortlessly create label documents and regulatory submission packs, eliminating human error and enhancing regulatory compliance. Authors across the globe can effortlessly retrieve pre-approved content, automatically populating their label templates.
Once the content completes its document lifecycle, the platform seamlessly facilitates publishing into Microsoft Word, PDF, and printed outputs. This streamlined omnichannel publishing approach not only reduces time to market and improves label quality.