Playing to the Rules is Serious Business in Pharma Artwork Management

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Investing in a robust and streamlined process for artwork management can result in significant saving in a stringently driven regulatory environment

A myriad array of rules and regulations dot the landscape of the pharmaceutical business. This industry has always been highly regulated, bur the exponential increase complexity of regulatory business requirements in recent years is mind-boggling. The truth is, there are no signs any let up in this relentless pursuit of regulatory compliance.

It is a double whammy for pharmaceutical companies. Not only have they to incur effort and costs towards compliance, they also need to reckon with the profound impact of non-compliance on cost, reputation, and patient safety.

Regulatory compliance in artwork management

When it comes to artwork packaging and management, it looks deceptively an innocuous back office function. Nothing could be further away from the truth.

Artwork management is a key and critical process in the stringently regulated world of pharmaceuticals. Needless to say, it comes with a bouquet of challenges. Keeping pace with and adhering to an ever-changing array of regulatory-driven requirements across the globe in a cost-effective manner is the main challenge. It calls for the right balance of business processes, design, technology, and infrastructure.

Let us look at the primary objective of compliance for a pharma company. Experiencing zero product recalls is a primary requirement. Faster turn-around time, greater transparency and a comprehensive system that enables multi-language, multi-cultural and multi-regulatory environments are other key objectives.

Artwork development and management, especially for large product portfolios on such a global stage is fraught with challenges. And that is why a streamlined process is critical – to avoid the following pitfalls

  • Overlooking significant information pertaining to current regulatory requirements in the design stage
  • Falling prey to contextual errors with ambiguous information
  • Omission and wrong usage of content.
  • Errors in the technical aspects of the artwork

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Needed – a robust Artwork Management System (AMS)

This is where a comprehensive AMS steps in. It enables pharma companies to sidestep and prevent negative implications of errors from causing costs to spiral and reputation to be eroded. Specialist partners can leverage their domain and process expertise to help pharmaceutical organizations with innovative, scalable and cost-effective solutions and services.

Such a process includes a well-integrated workflow comprising

  • Pre-submission check – for template adherence, consistency and content accuracy check
  • Post-submission check – for artwork design and approval, and further content verification
  • Quality analysis on content and format – using relevant and comprehensive checklists

In today’s digital era, digital packaging management systems can ensure control, quality, compliance and visibility to packaging and labeling processes. They can bring automated content models, structured content authoring (SCA), robotic process automation (RPA), and e-labeling. This, in turn, will increase productivity, improve compliance, and substantially bring down costs substantially.