Software Solutions for Regulatory Teams

With increased regulatory oversight and frequent product labeling changes, you’re under constant pressure to manage and update regulatory content. Eliminate the risk and simplify your company’s processes with the Esko | Brand Solutions digital toolkit. Control the quality and accuracy of each asset in a single, integrated platform.

Challenges for Regulatory Teams

Regulatory Compliance

Adhering to regulatory requirements across different geographies is not without its challenges. Impact analysis gives traceability of the product and the content so that the changes can be completed effectively, risk-free, and safely.

Lack of End-to-End Visibility

When regulatory teams don't have a centralized location for their projects, approvals, and more, they lose visibility of the entire process. Without a label and artwork management system, time to market is increased, and artwork, regulatory, and external departments don’t have access to the right content at the right time.

Risk of Errors and Recalls

Getting lost in the feedback? It’s confusing to manage multiple reviews of multiple files without a place to track all the information. Content has to be pulled from multiple locations and may be unavailable to easily re-use on updates to labels, artworks, IFUs, etc. Minimizing reviews reduces risk and allows the user to focus on one topic, avoiding errors.

Validated Systems

It’s imperative to use a validated system that can provide a fully compliant (21 CFR Part 11, Annex 11) audit trail and environment for the approval of artwork and labeling content.

Solutions for Regulatory Teams

Digital Audit Trails

Maintain compliance with FDA 21 CFR Part 11, EU Annex 11 through built-in compliance control tools such as ER/ES and audit trails. Use Esko technology and services to validate your labelling and artwork workflow solution according to GAMP5 industry best practices.

Artwork Workflow Management

Gain a holistic view of the label and artwork workflow, and greater process control, with the WebCenter artwork management solution. This spans across an entire organization as well as to 3rd parties involved in the process, such as pre-media, agencies, CMOs, printers, etc.

Content Management

Digital tools create efficiencies in your processes, which better equips you to handle the flux of regulatory changes, review and approval processes with multiple stakeholders, and growing localization requirements. Leveraging pre-approved content and artwork allows regulatory stakeholders to reduce recalls due to artwork errors.

Explore Software for Regulatory Teams

WebCenter Artwork Management

WebCenter is a powerful and user-friendly web-based platform that focuses on all aspects of labeling, from change request to release. It manages the lifecycle of labelling and artwork, from creation to retirement and can be configured to comply with the latest US FDA Part 11, EU or PIC/S Annex 11 regulations. WebCenter integrates with interactive artwork inspection tools to drive quality control in an end-to-end platform.

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Labeling and Structured Content Management

Content management is a solution that allows regulatory teams to specify, manage, and reuse content (text, claims, symbols, etc.) to be placed on artwork designs without manual copying and pasting. It’s an integrated module within the WebCenter artwork management solution that reduces risk, increases compliance, and saves time and money.

Submission documents, IFUs and labels can automatically be generated from Structured Content, reducing the lead time of content authoring and artwork generation from months to weeks with increased compliancy and error reduction.

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Automated Packshots

Automated packshots enable teams to go through as many rounds of review and approval as needed without going to physical production to troubleshoot. Artwork designers can utilize 3D design tools, available as plugins, in their existing creative platforms, such as Adobe Illustrator. Reduce errors and ensure compliance by creating GS1 compliant packshots.

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Studio 3D Design

Studio is a quick and easy way to turn your brand's product designs into beautiful 3D images for faster executive approval. Save time and reduce costs by virtually viewing designs and providing feedback. Reduce the need for physical mockups and incorporate products into lifestyle photography.

Learn More about Studio

The Esko | Brand Solutions Impact

Every day, Esko | Brand Solutions helps global companies create artwork, labels, and other content more efficiently. Our solutions unite labeling efforts across all participants. Use Esko to create synergies throughout your go-to-market process.

What Regulatory Teams Love about Our Solutions:

  • Adhere to compliance standards and improve control over the end-to-end label and artwork workflow
  • Connect all packaging and marketing teams, suppliers and agencies to a single source of truth
  • Ensure compliance and brand governance without decreasing productivity
  • Effortlessly scale to accommodate new products, new markets, and increasing SKU volumes

We won’t just tell you; we’ll show you! Browse our customer case studies below for an inside look at how our software has helped brands improve their processes.