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2 min read
Even when artwork packaging is often considered a seemingly insignificant back-office job, Artwork Pack Management is one of the key processes in the stringently regulated pharmaceutical and life sciences industries. For any given pharmaceutical or life sciences company, meeting the ever-changing, regulatory-driven requirements of global markets and finding cost-effective ways to maintain compliance standards is a constant challenge. With increasing regulatory inspections, global labeling harmonization efforts, and heightened focus on patient safety, artwork packaging accuracy has become business-critical.
To execute such a large-scale activity globally, the primary requirement is the right combination of business processes, design, information technology, and facilities. Today, this also includes digital artwork workflows, centralized artwork management platforms, and the integration of regulatory intelligence.
The primary objective of any organization is to achieve zero product recalls, a faster turnaround time, increased transparency, and an integrated model that supports multiple languages across global markets. In the current regulatory landscape, organizations are also expected to demonstrate audit readiness, version control, and traceability across the artwork lifecycle. However, when it comes to developing and managing artwork and packaging for large product portfolios that involve multiple stakeholders across regions and organizations, errors are inevitable. To streamline artwork processes and ensure regulatory compliance, organizations must proactively avoid certain anticipated errors.
Packaging Artwork Errors You Must Avoid
Gross Error:
This involves significant information being overlooked during the design and packaging of artwork. For instance, if an organization fails to update artwork in accordance with the latest regulatory requirement or health authority mandate, it can lead to non-compliance, product recalls, or market withdrawal. Such errors often arise due to poor change management and a lack of centralized regulatory artwork control.
Contextual Error:
When information is presented in an ambiguous, misleading, or unclear manner, it can lead to confusion among healthcare professionals and patients. Contextual errors are especially critical in multilingual labeling and region-specific regulatory submissions, where inaccurate phrasing or layout can lead to misinterpretation.
Content Error:
This includes any significant omission, incorrect usage of content, outdated safety information, or incorrect claims. With frequent regulatory updates from authorities such as the FDA, EMA, and other global health agencies, content errors pose high compliance risks.
Technical Error:
As the name suggests, this refers to errors in the technical aspects of artwork, such as incorrect barcodes, serialization issues, poor print quality, or incorrect dimensions. In today’s environment of track-and-trace, serialization, and digital packaging requirements, technical errors can disrupt supply chains and delay product launches.
To avoid the grave and far-reaching implications of such errors, which can impact patient safety, regulatory compliance, brand reputation, and overall operational costs, a robust Artwork Management System (AMS) is essential. Modern AMS solutions enable end-to-end artwork lifecycle management, automated quality checks, version control, and seamless collaboration across global teams.
Pharmaceutical and life sciences organizations can also benefit by partnering with specialized regulatory artwork service providers that combine deep regulatory expertise with creative and operational excellence. Such partners offer scalable, technology-enabled, and cost-effective regulatory artwork pack management solutions, supporting global compliance, faster approvals, and reduced rework across markets.
