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Q&A About Compliant Hands-Free Validation

Blog Home | Published: April 13, 2021

What is Hands-Free Validation?

Hands-Free Validation is the ability to perform validation tasks with no-or-low touch. In some instances, 100% Hands-Free Validation is possible and, in fact, recommended. This is especially true now during the COVID-19 pandemic where the need to eliminate exposure and transmission is the desired objective.

How is Hands-Free Validation Even Possible?

Technology has advanced exponentially offering more possibilities than ever before. Advances in Natural Language Processing (NLP), a combination of linguistics, computer science, artificial intelligence associated with human machine interface, allows us to issue voice commands to control devices, record data, take pictures and videos, and record sound. Coupled with Virtual Reality (VR) and Augmented Reality (AR), users can be immersed in a virtual world with the ability to see more than ever before, controlling and interacting with voice commands.

How Does this Apply to Validation?

A wearable device such as a headset is a self-contained computer that can be connected to the internet or other devices primarily via Wi-Fi or Bluetooth. As such, whatever you could do on a computer, tablet or smartphone can now be performed on a wearable headset. Since the headset operates with voice commands using NLP, no keyboard is needed. In fact, headsets can even read barcodes, eliminating the need for a hand-held barcode reader.

Is it Compliant with Part 11, Annex 11, and ALCOA+?

The device, along with the corresponding software, can be validated to prove it performs as intended. Devices are secured using voice recognition, username, password, and other forms of authentication. Objective evidence can be captured live, contemporaneously, including results (ASCII characters and numbers), audio (.wav), video (.mp4, .mpeg, etc.), and pictures (.jpg, .png, etc.). Data is recorded to a secured cloud that is fault tolerant, redundant, enduring, and available. All other requirements, including data integrity, can also be met and validated.

Is This a Fad or are There Real Benefits from Hands-Free Validation?

For the life sciences industry, this may be considered “new technology”, but it’s been around for 20 years. The United States Airforce has been using augmented reality since the 1990s. If it’s safe enough for a fighter jet, it’s probably something we can validate in life sciences.

COVID-19 has amplified the need for a hands-free solution. Paper-based systems highlighted the problem with paper. First, paper is a host that can carry and transmit a virus, among other things unclean. Second, how do you clean paper if it’s contaminated or an individual testing positive for COVID-19 has touched the paper? It can be done but it’s costly and consumes time. Therefore, paperless, hands-free validation has exploded onto the scene as a direct result of COVID-19.


Hands-free validation is the ability to perform validation tasks with no or low touch. In some instances, 100% hands-free validation is possible and actually recommended. (Especially relevant during the COVID-19 pandemic where hands-free validation eliminates exposure and transmission.)


Steve Thompson

Steve Thompson has worked in Life Sciences for over two decades in both Information Technology and Quality Assurance roles. He’s a certified systems auditor and has audited hundreds of companies globally. A published author, a frequent speaker at industry conferences, on the Board as a Director for PRCSQA, Editorial Advisory Board for ISPE, and Elite Faculty member for KENX, and Adjunct Lecturer, Temple University, School of Pharmacy, RA/QA Graduate Program. He was honored with an APEX 2020 award of excellence for a peer-reviewed article he co-authored for Pharmaceutical Engineering on Blockchain. Currently, as Director Industry Solutions at ValGenesis, Steve helps Life Science organizations realize the potential benefits of advanced technologies, along with inherent risks.