5 Reasons Why You Need a Label Audit Trail in the Pharma Industry

Rangan Das

June 22, 2022

The pharmaceutical industry can face costly repercussions due to the simplest of labeling errors. Here's how an audit trail can help not only reduce costs but also avoid errors.

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:

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.

Artwork Flow's audit log

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:

The audit trail keeps an eye on every team member’s action. So, when an error happens, such as an erroneous rejection or approval, or an undesirable change in the design, managers can see who is responsible. By communicating with the right person, the chances of such errors in the future are 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.

Monitor project status with Artwork Flow

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.

Artwork Flow's version control functionality

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:

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.

Closing thoughts

Label development for pharmaceutical products can be challenging, but with the right tools, you can simplify the process, bring in accountability, and create error-free labels. Get a demo to see how you can use Artwork Flow to accelerate label development projects.

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