In regulatory compliance, a manufacturing change or a health authority request marks the beginning of a meticulous process for your team.
You're tasked with assessing the impacts of the requests, submitting updates, and ensuring that all affected regions adhere to the new compliance standards. From planning and execution, to tracking each product you manage, it involves a keen awareness of many details and nuances. Overlooking any aspect could lead to delays or legal challenges, highlighting the critical role of regulatory compliance.
The challenge of maintaining regulatory compliance is magnified by the complexities of proofreading and document control. When you expand these operations globally, dealing with various regulatory bodies and health authorities, each with its own set of guidelines, languages, and submission requirements, the necessity for automated proofreading in the context of regulatory compliance becomes even more unmistakably clear.
Identifying Opportunities for Proofreading Optimization in Regulatory Compliance
When tracking regulatory compliance on your documents, opportunities for proofreading optimization pop up from the very beginning of the product development process.
Be it during the early authoring stages, where cross-functional teams iterate collaboratively through multiple revisions; all the way downstream to the printed cartons, labels and leaflets that, once dispatched, leave your direct control and become critical risk points for compliance. Not forgetting any additional approvals and MLR requests for various messaging and promotional content created around your product.
This extensive process, covering various regulations, languages, channels, and teams, raises an essential question for anyone aiming to enhance regulatory compliance through automated proofreading: where to begin?
Start with the Low Hanging Fruit for Regulatory Compliance
We operate under the assumption that any external document, text, or file represents a potential exposure to non-compliance. Thus, prioritizing parts of the document creation process that pose the highest risk of errors and delays is the simplest to address and can significantly impact regulatory compliance efforts.
Mapping out your regulatory workflow's common triggers and actions offers a high-level view, essential for identifying where automated proofreading can most effectively enhance regulatory compliance.
Leveraging Automated Proofreading Tools for Regulatory Compliance
Consider the scenario of a product-related change. Once the impact is assessed and relevant information is gathered, the pre-publishing stage becomes critical. This stage demands rigorous proofreading and revision control to prevent non-compliance related delays.
Here, introducing an automated proofreading tool like Verify can ensure that documents are meticulously inspected before release, significantly reducing the risk of non-compliance.
Implementing a fully validated and compliant web-based tool like Verify means that you can be up and running within weeks. Allowing you to ensure that all documents at that critical pre-publishing stage are thoroughly and efficiently inspected before they are released.
That kind of risk reduction with ease of implementation is your low hanging fruit and your first step towards regulatory compliance automation.
Defining Automation in the Context of Regulatory Compliance
Automation exists on a spectrum, where on one end (0% automation), you have a very manual process like proofreading, driven by your individual efforts as a user; and on the other end (100% automation) you have a fully completed outcome that you consume as a user.
You don’t just go from manual to automated in a couple of steps, you undertake a journey to automate small parts of your process in order to leverage the power of automation over time.
So, in order to set the table for our needs, we need to draw some boundaries on how we are defining automation for the very specific case of proofreading.
Let’s take a step back. When proofreading, you are essentially doing one simple thing: comparing what you are looking at to a source of truth.
Sometimes that source of truth is explicit, like a QRD, SPL document, or medical dictionary; and sometimes that source of truth is your own brain, it is implicit, where you compare what you are seeing to your own knowledge of grammar (in the case of spell checking) or your experience in dealing with a specific person at the FDA who needs a particular document formatted in a specific manner.
Either way, the exercise of proofreading here is the same, you reference what’s in front of you to one or more sources of truth. You might get multiple team members to do this, by setting up a review and approval process, adding time and costs to the process.
This is a tedious and time consuming task that has one true goal - finding errors. Errors that can cause real delays and costs that come as a result of non compliance.
Despite best efforts, the FDA reports 14,000 recalls over the past decade, amounting to about 4 recalls a day, meaning we still have a ways to go on this front. Thankfully, GlobalVision has been in the business of finding errors for over 30 years, helping the world's largest life sciences organizations reduce risk, automate processes and make proofreading more efficient.
Key Metrics for Proofreading Efficiency in Regulatory Compliance
To further enhance regulatory compliance, consider the following three metrics when expanding that definition across your regulatory workflow:
- Reducing Revisions: Document Development Speed
The authoring process differs depending on where you are in the product life cycle. Early in the cycle, document revisions and content creation make for many changes. Later on in the cycle, the document crystallizes and changes should be flagged for review. This is true from your digital files all the way downstream to the printed material. When automating this process, measuring and reducing your total revision count is a good indicator of whether or not you’re on the right track.
- Speed to Market: Reduce Cognitive Load Through Modular Content
When your team has too much to look at, and too much to consider at once, the probability of error increases.
When so much energy goes into the creation of approved documentation, be it for submission or marketing purposes, it makes sense to recycle and reuse that content across your organization. Your Document Management System should be set up for modular content. This will allow you to get to market faster by re-using approved text assets such as copyright statements, approved definitions and claims; as well as approved digital assets like logos and photos.
Using modular content, you will free up mental bandwidth for your team to focus on newer projects and new content creation.
Globalvision partners with leading DMS and AMS companies like Veeva and Esko to integrate seamlessly into your workflow combining the powers of modular content with automated proofreading for a higher speed to market.
- Facilitate Decision Making by Consolidating Proofreading
The tools you use need to reduce complexity, not increase it. The UI and workflow need to be clear and simple, so your team can quickly decide if a change is approved or rejected. The proofreading tool should highlight exactly what's changed, allow you to report on it, save your files and inspection to one location and be accessible anywhere, anytime.
Your proofreading activities should be consolidated in one place, so you can review more than just text, but also inspect your graphics, barcodes and braille elements.
Measure this by looking at the total inspection time for your documents before and after you implement a proofreading tool. If the amount of time spent proofreading is reduced, then you know that you’ve taken a firm step towards automation.
Continuous Improvement in Regulatory Compliance
We know that proofreading is often a thankless task. One that, when done correctly, no one notices, and when done incorrectly, your customer notices.
By strategically integrating automated proofreading tools like Verify and focusing on key performance metrics, you can significantly enhance regulatory compliance. The journey towards full automation requires continuous evaluation and adaptation, but starting with targeted solutions like Verify can demonstrate immediate benefits in maintaining regulatory compliance.
Take the next step and try it out for yourself! Compare your first set of documents in Verify and explore the value it can bring to your regulatory compliance team.
