For a global pharmaceuticals manufacturer, packaging is mission-critical. After all, without it, drugs don’t move. In the tightly-regulated market for prescription and over-the-counter drugs, the accuracy and ability to manage the ever-growing quantity of content that needs to fit on a label is paramount. Pharmaceutical manufacturers must comply with the increasing number of global and regional regulations, which adds levels of complexity to the process of managing labeling. Labeling errors can result in costly recalls and significant fines, as well as damage to the company’s brand and reputation.
For all these reasons, plus the need to meet various supply chain deadlines and factor in brand and translation requirements, developing new packaging artwork for a new drug or treatment can be a complex process.
The trouble with spreadsheets
This challenge is further exacerbated by the fact that many pharmaceutical manufacturers today still use spreadsheets (notably Excel) to manage their packaging and artwork processes. Extensive use of outdated technology of this sort often results in manual, time-consuming processes prone to errors and inconsistencies, which typically hold companies back when they're creating product label and packaging designs. Spreadsheets are relatively easy to access and most workers have a basic understanding of how to use them, but that’s where their advantages end.
At its heart, Artwork Management is about managing workflows, enabling collaboration, and ensuring good content management, but you can’t store images in a spreadsheet. At most, you can put in a note as to where they should be found in a directory. This works until someone moves a piece of artwork without updating the directory, or vice versa. This happenstance is more likely than not, as 88% of enterprise spreadsheets are known to contain errata.
Second, there’s no good way to store annotations or conversations. To be fair, a collaborative solution such as Google Sheets lets different users type in comments on various action items, but no one wants to read any comment, no matter how constructive, if it’s squashed into a little cell in a spreadsheet. Not to mention, it is very difficult to find a particular comment in the middle of a vast spreadsheet with multiple lines and dozens of pages.
Lastly, and most importantly, there’s no good way to implement version control on a spreadsheet. There’s a lack of structure and accountability. Effectively, there are only two ways – emailing every team member a new version of the spreadsheet whenever you make a change, or collaboratively making changes in a cloud spreadsheet. Both ways are bad. One can make changes in the cloud, but it’s hard to see who made those changes, what changes were made, or when they were made. If the changes are wrong, then it’s hard to roll them back. Email is a complete non-starter – people will lose the email thread, lose the files, and work off incomplete or wrong-version documents without noticing that they’re out of date.
This kind of logjam isn’t just an obstacle to efficiency. Rather, it creates the very real danger that a product will go to market with the wrong version of artwork or potentially with an error. In the best-case scenario, the mistake is something small –an incorrect color or design component, let’s say. Worst-case scenario, the mistake is something very serious, like getting the dosage information wrong on a carton of medication or missing an allergen listing on a food product.
As it happens, the worst-case scenario occurs relatively often. According to a report by Kaiser Health News, roughly 8,000 brands of medication underwent recalls from January 2013 to October 2018. Moreover, evidence indicates about 50% of all pharmaceutical recalls are believed to be based on errors in product labeling and artwork.
Recalls typically also involve a plethora of costs – there’s the cost of sending recall notifications, the cost of destroying or repackaging a recalled product, brand damage, and even fines and lawsuits.
Finding a solution
To address and mitigate these challenges and manage product artwork efficiently, organizations need an automated artwork approval process, supported by an automated and configurable Artwork Management system, that can be incorporated into their product lifecycle and managed across their global enterprise.
The capabilities that this approach can deliver are far more efficient than spreadsheets and can help streamline the Artwork Management process and enable compliance through full version control, and audit and traceability reports. For example, a fully automated Artwork Management solution will track all workflows to keep a permanent record of all approval points, status, dates, and users. Role-based access provides extra security and e-Signatures enable traceability that shows who made a change and when.
Organizations can build out workflows requiring project managers to incorporate necessary packaging requirements at the outset. Once these prerequisites are outlined, the first phase of packaging artwork can begin and will trigger each progressive step automatically.
Organizations can set up advanced content management to streamline the review and approval of artwork and packaging copy in highly-regulated industries.
Extending collaboration to partners, vendors, and suppliers makes everyone’s job easier. When everyone has real-time visibility into the product packaging, you see where your packaging is in the product lifecycle, and who or what is holding it up.
The ability to manage localized content enables businesses engaged in Artwork Management to create, manage, track and use multiple phrases to describe the same product in different countries worldwide. Datasheets can be used to replace Excel to manage project content more efficiently; help with collaboration, and track progress on the roll-out of artwork.
Once the packaging artwork has been approved by all stakeholders, it can then be automatically saved into a digital asset library giving everyone access to the latest file and document ready to print. Housing all your artwork files, artwork versions, videos, die cuts, finished artwork, brand docs, images, and packaging in the same platform you use to approve the content makes life easier for everyone.
Managing control of content used in packaging artwork is critical to meeting deadlines, ensuring compliance, and enforcing brand consistency. An automated and configurable Artwork Management solution allows users to exert this level of control over their processes and projects. With the most efficient Artwork Management systems, organizations can create dashboards from which they can have oversight, and filter and slice and dice everything that is going on in their packaging processes. The end benefit here is enhanced visibility and the insight that provides the opportunity to address bottlenecks and create new efficiencies.
Forget about spreadsheets - Why a digital Artwork Management solution can be the answer
Managing packaging artwork is never easy, but you don’t need to let manual processes overwhelm you. With today’s increasing pressure to get products to market by turning around compliant packaging artwork more efficiently, the manual spreadsheet-based approaches of the past are no longer viable. Forward-thinking companies are turning to digital, automated solutions to manage and control the process to achieve compliance. With a digital Artwork Management solution, you can eliminate spreadsheets and manual processes to streamline your packaging lifecycle to get to market faster and gain the edge over your competition.
*This thought leadership article first appeared in European Pharmaceutical Manufacturer