Step-by-step Process Overview of Regulatory Artworks

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Step-by-step Process Overview of Regulatory Artworks

With years of time spent on innovating new drugs, life sciences organizations, sometimes, take a backseat to allocate sufficient time for artwork design processes that result in inaccurate and incompliant marketing of products followed by product recalls affecting the overall costs. With defined Regulatory artwork processes, organizations can sustain critical situations like these especially in time-bound pressures.

What exactly are defined artwork processes?

Defined artwork processes are standardized procedures for managing artwork creation as per pre-defined source files, dielines, brand guidelines, and print supplier requirements from a central web-based enterprise platform – Artwork Design and Pack Management system. Right from gathering the required content to delivery and distribution of a given product, the system defines the steps involved to release error-free artworks consistently with minimal effort. Such as:

  • Content Collation: All related project information is usually scattered at multiple locations. The primary requirement is to gather all the source files, specification files, key lines and briefs for reference.
  • Artwork Creation: To begin with, the core design team primarily requires expertise in Illustrator, Indesign, Quark Express, and few other specialized designing software. Secondly, the team must have a basic understanding of the market, site and print supplier requirements.
  • Version Control: The version control keeps track of all created drafts and versions of an artwork file. It also regulates all approvals and authorizations of new artworks, along with systematic control to identify the latest artwork for amendments.
  • Artwork Approvals: The robust web-basedArtwork Management System does not involve the hassle of paperwork. All functional approvals during the artwork process is carried out through electronic signatures on electronically stored originals.
  • Digital Asset Management: In the regulated industry, authorities and quality standards define high demands on how records such as files and information are stored and maintained in electronic archives. The archiving system must comply with requirements for audit trail, electronic signatures, version control.
  • Delivery and Distribution: Once the artwork and print-proof approvals are done, the order is released for production, delivery, and distribution.

What appears as simple types of packages, namely, labels, cartons, leaflets etc. require concerted effort of different parties and sponsors which take months for beautification and presentable with. print-ready artwork. Not only reducing the compliance risk, but also making the artwork creation process cost-effective poses significant challenges for the manufacturers and marketers. A regulatory solutions and services provider with defined artwork design and pack management system could prove useful during large-scale productions for biopharmaceutical companies.