We’ve all heard the saying: “Time is money”. If you are in Regulatory Affairs, like most of our customers are, then you are surely short on time—which is costing your company money. But what if there was a way to reduce the time you spent on one time-consuming and error-prone task? In this article, we will be exploring the task of proofreading in Regulatory Affairs, and five ways RA departments are wasting money if they are proofreading using the old fashioned “manual” method (i.e. using human eyes only going line by line, item by item).
1. You’re using too many human eyes
Call it the four-eye principle, call it 200% proofreading. Everything must be absolutely right in regulatory affairs, which often means that at least two people are needed to proofread manually the same document. And people are expensive. The cost per hour of work of the employee doing the proofreading includes the salary but also taxes, benefits, insurance and so on, which can more than double said salary.
Digitizing your proofreading process with a proofreading software specialised in Regulatory Affairs allows one person to do the comparison. The software acts as the second set of eyes, and the process is much faster since any differences between a master document, proofread by a specialised employee, and secondary documents are identified immediately. A professional is needed to make the final review decisions, but only needs to review what is highlighted and not the entire document from top to bottom. For example, after implementing a proofreading software specialised in Regulatory Affairs, the CRO Biomapas was able to save two days of review time per piece and only needed one person to do the work instead of two. This resulted in significant cost savings.
2. You have more “high value” things to do
Would you drive a high-end luxury car along a rough gravel track? Probably not. So why are you, a highly trained RA professional, spending countless hours marking up proofreading changes? Although it is your responsibility to ensure that drug or device information printed or published is accurate, the act of proofreading is not really what you’re trained for. Along with planning and overseeing product trials, managing regulatory registrations and product approvals are just some of the tasks on your long list of responsibilities. Using a regulatory proofreading software to review, manage and save all your mark-ups can give you the freedom to work on aspects of your job that cannot be left to a software solution.
Regulations change, versions of regulations change; what’s new and what’s in the old regulations? Keeping up with regulations was a concern for up to 50% of participants in a RA survey published in the 2021 RAPS workforce report*. With a regulatory proofreading software, you can run different versions of guidance and regulations through the tool to instantly see changes – saving you even more time and putting you ahead of the game.
3. You’re stuck in a correction cycle hamster wheel
When three or four people are checking, rechecking and reworking the same document, they don’t always communicate in the same way or accurately rewrite comments and annotations. Instructions become ambiguous at best – or worse, confused and misleading. As documents are passed to different departments, inconsistent communication leads to more errors, more revisions, more comments and more mistakes. A last minute rework because of a mistake identified late in the process takes time and could delay production. For each day that a product is not on store shelves, sales are lost and competitors have the advantage.
Regulatory proofreading software streamlines and focuses communication. Annotations and changes are clearly marked, and everything is saved in one audit trail compliant report, resulting in fewer revision cycles and allowing products to get to market sooner.
4. Juggling project files in multiple languages
Most life science companies need to deal with labeling and packaging in multiple languages all of which must be checked. That might mean managing, say, 10 different files in different languages in different versions, working with up to 10 different native speakers. Does that sound familiar?
Now imagine you could review all languages in one shot. The project lead can run a comparison in a regulatory proofreading software on all languages and any deviations and spelling mistakes are highlighted for checking. A report with these deviations can then be distributed to native speakers, who clarify and correct only the identified deviations. It’s simple and in one project.
5. You’re not using a tool specifically for Regulatory Affairs
There are several comparison tools on the market, including some free online versions, but these text comparison tools have clear limitations for RA professionals. For example, these tools do not allow you compare different file formats (ex: Word to PDF), or if they do, they may covert files to PDF format and then compare them visually. This type of document conversion goes against data integrity principles and is a violation of GMP processes. This can lead regulators to question the validity of comparisons and the entire packaging review process at your organization.
A regulatory proofreading software is built specifically for Regulatory Affairs, and therefore can handle vital tasks such as:
- Comparing text and artwork in any file format
- Decoding and grading barcodes
- Performing many-to-one comparisons, useful when reviewing leaflets or manuals that contain multiple languages
- Verifying text reading order, essential for visually impaired patients
- Checking for critical words such as brand and product names
- Ensuring the correct spelling of medical words and terms with an embedded medical dictionary
- Formatting, including font size, font name, bold italic etc.
- Supporting SPL and QRD templates
- Providing an audit trail report
- Remaining compliant with 21 CFR Part 11 and Annex 11
A RA professional recently posted on LinkedIn that “Paranoia is RAs best friend”. They were alluding to the process of checking everything over and over to make sure they didn’t miss a mistake. We felt this was an interesting post, because it shed a light on the high stress that can be felt in this role. But what if not all aspects of your job need to feel like this?
Based on our experience working with Regulatory Affairs professionals for over 20 years, we have discovered that using a Regulatory proofreading software, like TVT, our Text Verification Tool, can save you over 80% of your time compared to manual proofreading.
But what does that mean in actual dollar savings? Based on a recent customer survey we conducted, companies using TVT are saving on average 5 hours per week versus manual proofreading. Extrapolating this against the average salary of a specialised Regulatory Affairs employee with about 5 years of experience (estimated at US$114,117 or €71.777), this works out at a yearly saving/productivity increase of US$14,500 or €9.000 per RA user, not to mention all the other work that can be accomplished and the reduced stress from knowing no mistakes were missed during the proofreading process.
If you are interested in learning how you can stop wasting money on proofreading, get in touch; we will show more ways in which TVT can help you.