In the late 1980s, I recall trying to get approval to purchase a cell phone. At that time, I worked in the EPA-regulated industry with hydrogeologists who worked in the groundwater studies field. It seemed beneficial to be able to communicate while out in an open, empty field. My request was firmly rejected.
Fast forward to today. My cell phone is always with me; if I forget it when I leave home, I must turn around and retrieve it. The cell phone has gone from a gadget to an essential tool — much like the laptop computer. Once considered a nice-to-have, the laptop has become a necessity in daily life and the best choice for a personal computer. But what about the tablet computer, especially in GMP environments? Is it the latest gadget or a practical, best-choice tool for life sciences manufacturing? In my opinion, it’s the latter.
Here are four reasons tablet computers are ideal for validating computer systems, equipment, and instruments in controlled manufacturing environments.
We know that a contamination plume cloud surrounds everyone, which is why we must gown up to enter a sterile area. However, it’s important to note that gloves alone do not provide complete protection from hand contamination. Suppose the only computer in a controlled cleanroom environment is a desktop PC multiple users share. In that case, everyone who touches the computer spreads whatever may be present on their body (i.e., their plume) or on their hands, which causes cross-contamination, and the problem grows exponentially.
You can wipe down the computer daily, but adequately cleaning peripheral devices like keyboards, which are highly prone to contamination, is particularly challenging. According to WebMD, a computer keyboard is one of the germiest items you touch daily. Only cell phones and remote controls are germier.1 Imagine blasting a can of compressed air in a cleanroom! Your plume would become a nanoparticle cloud of contamination floating around, jeopardizing everything in its way. Sharing a dedicated desktop computer is far from ideal, but allowing staff members to use individual portable laptops is worse.
For fun, have someone from the QC lab swab commonly touched public surface areas around your workplace, e.g., handrails, elevator buttons, doorknobs, break room appliances (microwaves, water dispensers, coffee pots, etc.), and drawer handles. It’s staggering how much we inadvertently contaminate just doing our job.
But how would a tablet be any better? The primary reason is the keyboard. A tablet has a glass screen you can sterilize and sanitize much more effectively than a standard desktop keyboard. Plus, a tablet can (and should) be dedicated to the GMP area/cleanroom to minimize contamination with the outside world.
No doubt you are aware of ALCOA+ data integrity principles. The “C” in the ALCOA acronym stands for contemporaneous, which means occurring at that time, not recorded later. When we use appropriate technology in the life sciences, it complies with regulatory requirements; is validated and secure; has an audit trail with the date and time stamp; identifies and authenticates the individual performing the task; and records data contemporaneously. If you need to enter a result, scan a barcode, or record a video for objective evidence while on the manufacturing floor and cannot access a desktop computer, recording data contemporaneously is impossible. A tablet lets you record the data immediately and contemporaneously and create an audit trail with date and time stamps that flow in order of execution, proving the data is credible.
ValGenesis e-Logbook takes the convenience of tablets one step further by enabling you to execute test cases on the production floor without worrying about network connectivity or carrying a paper-based protocol or bulky laptop. Mobile validation empowers you to keep critical processes moving when you cannot access your computer or are away from your desk. This saves time, money, and personnel hours.
We’ve already discussed some compliance-related items: ALCOA and data integrity, audit trails, security, and authenticating an individual user’s rights to access the system and manage the data, but there's more. We must also provide objective evidence to support our actions in performing tasks, e.g., a screenshot taken during validation execution.
With a tablet, you can use the camera to take a picture contemporaneously to prove you validated that piece of equipment, in that location, at that point in time. In other words, it bolsters your objective evidence, making your task, validation, and data more accurate, reliable, and defensible during an audit or inspection.
The IT department in your organization strives to control devices to secure your computing environment. This is more challenging with a desktop PC. Locking down a personal computer hampers an employee’s ability to perform and creates frustration. Being too lax creates bigger issues and security challenges.
If a computer attached to the network in a controlled GMP environment is infected, the virus could contaminate nearby devices. Heating, ventilation, and air conditioning (HVAC), Internet of Things (IoT), and programmable logic controller (PLC) devices are security risks because they may not receive the same rigorous testing and validation as an enterprisewide computer system. They may not be on IT’s security radar as much as personal devices connected to the corporate network, but they should be. Nefarious hackers are always looking for a crack in security to enter, pivot, infect, then exploit nearby devices to spread the virus (e.g., malware, worm, spider) across the corporate computing infrastructure.
A tablet computer will not fix a security crack in your HVAC, IoT, or PLC devices, but it will keep infected laptops out because you’ll be able to prohibit individuals from bringing their personal computer into the controlled area. End users are less frustrated because the tablet is a special-purpose device, not their personal computing device.
We have given four key reasons why tablet computers are well-suited, possibly ideal technology tools for controlled, clean GMP manufacturing environments — but there are more.
Tablets make it easier to take advantage of web-based data logging applications like ValGenesis e-Logbook, which allows you to scan barcodes and QR codes on the manufacturing floor. Digital solutions eliminate the disadvantages of using paper logbooks and manual data entry to record and track equipment use, cleaning status, and other manufacturing activities. Some of these disadvantages include illegible or incomplete information, lost logbooks, contamination, and other compliance risks. With e-Logbook, you can track and maintain any type of GMP log across any device, improving data integrity, efficiency, and inspection and audit readiness. And again, because tablets are easier to sanitize than laptops, your processes are significantly more sanitary.
Another advantage of tablets is the ability to record sound and video more easily. Sure, you could make these recordings on a cell phone but remember, cell phones claim the #1 spot on WebMD’s germy list. Cameras on a laptop are less than ideal when you are mobile and trying to record the objective evidence required by good documentation practice (GDocP) and good manufacturing practice (GMP). It isn’t easy to hold a laptop while trying to execute a protocol, snap a picture, or record a video.
Physical safety is yet another factor to consider. Because they are smaller, lighter, and more portable than laptops, tablets allow engineers and technicians to move more freely around the lab or plant floor, which could reduce trips, falls, and other workplace injuries. Trying to use your laptop while holding it and walking along the manufacturing floor is an accident waiting to happen, and not what it was designed for. Laptops were designed to be used at your desk or on your lap. Desks are not prevalent on manufacturing floors, and you'll find it difficult to sit on the manufacturing floor and work on a laptop. As an added benefit, laptops have a longer battery life.
Tablet computers are ideal for designing more efficient, cost-effective manufacturing processes and safer, more productive workspaces. If you would like to see how validation can be executed or GMP logs can be maintained using tablets, contact us for a demo.