Table of contents
The RA team needed a faster way to review IFUs and labels
Given the company’s rapid growth, spending hours — or even days — on going through documents line-by-line was no longer feasible.
New World Medical specializes in the design and manufacture of innovative surgical devices for glaucoma treatment that are distributed worldwide.
Previously team members had to go through documents line-by-line several times to make sure labels and IFUs are error-free. This approach was too time-consuming to stay sustainable for the growing company.
Recognizing this, Senior Regulatory Affairs Specialist Kejdi Tafili started looking into alternatives to manual proofreading together with his line manager.
“Our intention had been to really find the perfect automated proofreading solution for our company, and once we did, we wanted to move forward as quickly as possible so we can really save resources and improve time management for our proofreaders.”
Kejdi Tafili
Senior Regulatory Affairs Specialist
“Making sure we do it correctly and in that short period of time is very important to us.”
Kejdi Tafili
Senior Regulatory Affairs Specialist2-month testing period to find the right tool for text and image verification
8 users from the RA team tested different solutions for 2 months.
By the end of the trial, the team was convinced that TVT was the best solution for them.
They were impressed by TVT’s performance for image and artwork verification.
Another factor that made TVT very attractive for New World Medical was the validation package offered by Schlafender Hase.
“Schlafender Hase was very thorough in explaining how TVT works, including any technical aspects, and worked closely with our technical staff.”
Kejdi Tafili
Senior Regulatory Affairs Specialist
“They were very thorough in their explanations of TVT and really walking us through the process and how to use TVT”
Kejdi Tafili
Senior Regulatory Affairs SpecialistAdding new use cases beyond IFU checks
Given New World Medical’s presence in 88 countries, they’re now planning to check translated IFUs and labels with TVT to find content deviations.
New World Medical uses TVT, TVT Artwork and TVT Spelling for IFU verification.
Here are some of the use cases they plan to add:
- verification of translated labels and IFUs,
- finding changes in SOPs and other large internal documents, and
- tracking changes in relevant external documentation, such as updated regulatory documents.
“TVT will really help us in our current expansion into more countries and regions, especially for verifying IFUs in multiple languages.”
Kejdi Tafili
Senior Regulatory Affairs Specialist
“Another thing we're going to use TVT for is to make sure that we incorporate those translations in IFU correctly, based on the proofs that were provided to us.”
Kejdi Tafili
Senior Regulatory Affairs SpecialistTVT demoUse TVT to speed up reviews
See how TVT and TVT add-on modules can be used for faster text, image, or barcode verification across multiple use cases.
Start your free guided trial after the demo.
