Why regulatory affairs professionals need document comparison software
Changing times require new processes. In the past, Regulatory Affairs professionals proofread manually. One person would read aloud while another marked the document.
With technological advancements, this process can be automated using a comparison software. The major players in the Pharma and Medical Devices industries have either adopted or are in the process of adopting software for document comparison. Similar to other technologies, its adoption has been slow despite it’s proven time, money and stress savings. The goal of this article is to explain how document comparison software can help and why it is an essential part of any Regulatory Affairs (RA) tech stack.
What is proofreading for Regulatory Affairs professionals?
When we talk about proofreading in general, we mean finding and correcting mistakes in written text. This is correct when talking about proofreading a book or a school essay. In the life sciences industry, proofreading means much more. Packaging and labeling include elements such as dosage, instructions/directions for use, company logos and numerous other graphics, as well as a variety of different barcodes. Everything has a purpose and must be correct before your product hits the market.
Ensuring consistency and compliance is of absolute importance. Whatever the format (including online and hardcopy/print), all versions must be true to their original throughout the entire lifecycle. And the content format (font, type size, etc.) must be compliant with local regulatory specifications. A mistake could cause a misprint resulting in a CAPA (corrective and preventive action), a recall, or even worse, negatively affect a patient’s life.
If your job is to sometimes check or compare versions of a document for errors, you might not even realize that what you’re actually doing is proofreading.
What is document comparison software for Regulatory Affairs?
Document comparison (or proofreading) software for Regulatory Affairs allows RA professionals to compare digital files with different layouts and in different formats (ex: Word to PDF) to catch any potential deviations early in the process. The software will instantly “proofread” and identify any deviations between the two digital files (ex: font size, graphics, font style, barcodes, spelling, etc.) You just need to determine whether these deviations are acceptable or not.
The software is very simple and easy to use:
- Upload and compare your documents
- Review and comment on any identified deviations
- Approve the content
Finally, an Audit Trail Report can be generated and saved to ensure worldwide compliance.
By implementing a comparison software, RA teams experience:
- Reduced proofreading workload (only one person is needed to proofread)
- Peace of mind that their label is accurate and safe for patients (less stress)
- Reduced correction cycles (more time to do other tasks)
- Improved document consistency across departments (no more misprints and recalls)
It is no surprise that all the top 20 global pharma and medical device manufacturing companies already use a document comparison software for regulatory affairs instead of manually proofreading.
Why is document comparison software needed in Regulatory Affairs?
Proofreading is crucial in life sciences and serves as an integral part of the quality control process. Traditionally, this process has been manual (usually two people checking things line by line, item by item with sometimes a third verifying their work). Using highly qualified RA professionals to proofread isn’t only very expensive, but also inefficient.
We recently spoke to a customer that told us that before using our comparison software, both their labeling person and regulatory lead would spend half a day (8 hours total) manually proofreading one prescribing information (PI).
Based on industry salaries we gathered from RAPS, this comes to $461/PI. With 32 products in their portfolio, and a number of corrections/changes by FDA, this easily leads to an average of at least 1 to 2 PI corrections each week. That’s $47,494 /year just in manual proofreading costs! They are now doing the same amount of work in two hours total with our document comparison software.
Using a document comparison software for regulatory affairs eliminates the risk of human error. Users can quickly identify errors and inconsistencies in their documentation, labeling, packaging, and other materials that can lead to mistakes, misprints and recalls.
Deviations such as a missing character (ex: 1 mg instead of 10 mg), a missing dash (ex: take a tablet 12 times a day instead of take a tablet 1-2 times a day) or duplicated words (ex: Do not not chew instead of Do not chew) are some common deviations that are easily overlooked by the human eye.
For more information on how a comparison software for regulatory affairs can improve your work life, we’ve put together a list of the top 10 ways using a comparison software to automate proofreading makes your life easier.
The Industry Standard – TVT
TVT, the Text Verification Tool, is custom built for regulatory affairs with specific features included that address the unique needs of the industry. TVT has become the industry standard and is regularly listed as an asset when life science companies are posting regulatory affairs jobs. Using it is a skill that many Regulatory Affairs professionals list on their resume.
According to a Regulatory Affairs Manager at Teva, “TVT has the potential to revolutionize how we work in regulatory affairs, dramatically reducing ‘dead’ proofreading time that can be spent on more value-adding activities. I wish I’d known about this proofreading solution years ago!”
TVT is a validated software that can verify text, spelling in over 45 languages, artwork and barcodes (including country-specific Health Authority Codes) all in one project. It will also generate a complete audit trail report. It is EMA (Annex 11) and FDA (21 CFR Part 11) compliant and supports the latest QRD, SPL and SPM submission formats.
Typical uses for TVT include reviewing leaflets, labels, cartons, inserts, packaging, submissions, CCDS, SPC/SmPC, SPL, SPM, QRD, IFU/DFU/Manuals, Printer’s Proofs, Marketing Materials, etc.
According to Erika Galiatsos, Corporation Manager, Labeling, Regulatory Affairs at Interchem “Purchasing TVT was a very wise business decision. The software has been an enormous asset to our department. It has cut down on the time it takes to proofread, allowing us to accomplish our goals more quickly and efficiently.”
Tips for implementing a document comparison software for your team
Before taking the step to bringing in a new technology into your organization, it is important that all the stakeholders are on board with the process and expectations this new technology will bring. This is especially true in life sciences when things like integration with existing systems/processes, validation and data integrity are essential.
If you are considering implementing a comparison software for regulatory affairs here is a list of 13 questions to ask yourself and your team before making a final choice.
There is a need for RA professionals to ensure the content reads correctly within its context and make the final decisions today. A comparison software for regulatory affairs like TVT helps speed up this process while ensuring consistency and compliance across the lifecycle of your content.