When it comes to label design and development, the pharmaceutical industry faces some unique challenges that are not quite present in other industries. A minor error can lead to a complete recall of the product, leading to massive losses. Common errors often include missing hyphens, use of double negatives, or embarrassing typos.
Almost 40% of the recalls that take place for pharmaceutical products happen because of such labeling errors.
But how do you ensure that such errors are taken care of, and more importantly, never introduced in the first place? The answer is audit trails.
Here are five reasons why you need audit trails in your product labeling workflow.
1. Traceability is crucial
One of the key requirements in any product labeling project is traceability. Product label development often involves multiple stakeholders, each of them having their responsibility in the project. A non-exhaustive list includes:
- Developing and communicating the design ideas
- Creating a final design for the product
- Reviewing the design and providing feedback on time
- Ensuring regulatory compliance
- Sharing design and packaging specifications with print vendors
While this list is an oversimplified version, it still shows that a lot of tasks take place during these label development projects. Traceability becomes important in such complex projects to keep track of the progress of the project and the changes being made through the feedback loops.
No design is perfect in the first iteration and the development takes place over multiple feedback iterations. With an artwork management tool, tracking changes and understanding who approved what becomes much easier.
2. User accountability is non-negotiable
Even with the most reliable team, slip-ups happen. You cannot eliminate human errors from the system entirely. However, when one happens, it is important to know the team member who is responsible for the error.
An audit trail enforces accountability by keeping track of every action that is taking place for a certain project. With an artwork management platform that comes with a built-in auditing system, you can see:
- What assets were changed by the design team
- Which stakeholders approved or rejected which changes
- The feedback provided by the stakeholders
- How the feedback was handled by the design team
The audit trail, integrated with the proofing software, meticulously tracks every team member’s action. So, in the event of an error, such as an erroneous rejection or approval, or an undesirable change in the design, managers can easily identify the responsible party. By promptly communicating with the right person through the audit trail, the chances of recurring errors are significantly reduced.
3. Eliminate errors at their source
Artwork management platforms such as Artwork Flow provide managers with complete visibility of the project. While the dashboard provides an overview of every running project, the audit trail gives all the nitty-gritty details related to the progress of the project. An audit trail for an ongoing project can help optimize the project workflow in two ways.
- Address errors before they make it to production.
While it is the job of the reviewers to address design issues and provide feedback to the designers, the reviewers are also prone to human errors. An audit trail allows you to see which reviewers are having trouble, allowing you to reassign tasks or reviewers.
- Reduce delays from bottlenecks.
Audit trails allow you to see which team members crossed the deadline with their tasks. You can then reassign them to other projects or communicate with them during the later stages to ensure they deliver on or before the deadline.
4. It makes version control easier
Artwork management platforms come with their attached cloud storage solution for storing design assets. This online cloud storage acts as the single source of truth for an ongoing project. A key advantage of this storage over any other cloud storage is that it comes with file versioning.
File versioning allows you to revert to an older version of a file in case of any undesirable changes. An undesirable change to a file may include a design modification or even a file deletion. While the version control system keeps track of all the changes to a file, the audit trail tells you how made the changes.
5. It is a regulatory requirement
Audit trails are not just a mechanism to enforce accountability, but they are also a critical regulatory requirement. The Food and Drug Administration (FDA) has strict regulatory requirements for document management systems which includes pharmaceutical labeling. According to the 21 CFR part 11, the brand must maintain audit trails that capture changes to critical data. Their requirements include:
- Capturing the date, time, and sequence of events
- Containing the complete history of the document
- Mentioning the personnel responsible for the document
The FDA also requires stakeholders to use electronic signatures to approve changes to a document. FDA has defined what qualifies as an electronic signature. Artwork Flow provides FDA-compliant electronic signature systems that work together with its audit trail to provide a fully compliant pharmaceutical labeling solution.
Meet your drug labeling requirements easily with ComplyAI
Accurate drug labeling holds more weightage, especially when it comes to safeguarding human health. These drug labels are more than just product information — it communicates to the consumer on what is present in the drug.
Any inaccuracies, even seemingly minor, can lead to jeopardizing consumer safety, even leading to fatalities like hospitalization and death. With Artwork Flow’s ComplyAI, you simply have to build your rulebooks and our AI engine will do its magic.
Let’s understand how Comply AI works with a recent safety labeling change for TECARTUS (brexucabtagene autoleucel), which led to serious T-cell malignancies (about seven percent of all NHLs in the United States) leading to death and hospitalization. Here’s how you can make drug labels FDA compliant with Comply AI.
You can build your rulebook by using “TECARTUS (brexucabtagene autoleucel)” as the preferred word. Our AI engine will run across all your labels and will simply throw light on all the labels with the absence of the preferred word. This way, you can change your label copy and get it right in front of your customers.
Accurately labeling your drugs is not a choice, but a compulsion. Remember, when it comes to human health there’s no room for error. Make all FDA complaint drug labels with Artwork Flow’s ComplyAI.Book a demo today.
