VIDA IS SET FOR THE US MARKET WITH 21CFR PART 11 CERTIFICATION
We are pleased to announce that VIDA has passed the necessary compliance standard for the US marketplace in achieving the 21CFR Part 11 certification, enabling VIDA to be trialled and sold in the US.
Having successfully trialled VIDA in laboratories throughout the UK, including Teesside University which reported 100% accuracy on all data collected, this regulation is a big milestone for us. This enables us to take VIDA to an international level, extending its possibilities to impact data collection in labs outside of the UK.
VIDA is an automatic and electronic technology that has been created in collaboration with lab managers worldwide to help eliminate the risks that can be associated with manual data collection methods in labs, whilst also improving workflow and productivity.
Created by our in-house dedicated manufacturing team, VIDA is a product for an international market, now with the necessary compliance standard needed for use in the US. The regulation, Title 21CFR Part 11 is critical for any manufacturer approaching the US market who builds and supports systems that are used by companies in the life-science sector. Established by the Food and Drug Administration (FDA), this regulation defines the criteria under which Electronic Records and Electronic Signatures are considered trustworthy, reliable, and equivalent to paper records.
Joanne Hockaday, project manager for VIDA at Martel Instruments, said: “Since the launch of VIDA, we have been aiming to approach the US market as we knew we had created something with international potential. We have become absorbed in the laboratory market in the UK and realised the need for a product with VIDA’s data transfer capabilities, and what this means for improving data transfer within labs worldwide.
“Achieving this standard opens VIDA up to help more lab managers, teams and technicians, and for that we couldn’t be more thrilled. The feedback we’ve received so far from trials in the UK secures our vision that VIDA really is a product with massive potential. We need more people to trial VIDA and experience first-hand this truly unique product.”
During the Covid-19 pandemic period, we have been utilising our online resources to virtually demonstrate the capabilities of VIDA with international labs. We have also attended overseas events virtually and have created the new VIDA website to accommodate international enquiries. Our new VIDA animation highlights all of the benefits of the automatic data collection that VIDA provides.
We are also in the process of building a virtual reality experience so that VIDA can be demonstrated to lab managers, live online. This means that despite current travel and meeting restrictions , you can still experience VIDA .
VIDA is also still available for trial in labs in the UK and US to tackle the day-to-day-challenges for lab teams during data recording. Inaccurate data recordings can lead to costly fines for lab teams and most processes currently are paper-based. Martel Instruments arranges the sending, set up and return of its VIDA technology for labs who sign-up for its 30-day trial process.
Electronic and paper-less, VIDA has been designed to eliminate the risks associated with manual data collection methods in labs, including human error. It also helps labs to better meet regulatory and compliance standards due to its accurate and guaranteed data collection and problem-solving features.
To find out more information on how to set up a trial of VIDA in your lab, contact our team today. We are always on hand to help and look forward to starting this journey with you.