Automated systems can be a big investment. So much so that it’s likely you’ve already spent significant time evaluating, selecting, and budgeting for the automated components comprising or expanding the system. Of course, this is because you want to ensure that the automated investment will maximally benefit your institution and project.
So why shortchange your due diligence efforts and incur risk to your unique process by skipping out on detailed testing opportunities prior to installation?
This is where factory acceptance testing (FAT) is an invaluable opportunity.
Factory Acceptance Testing (FAT) is a key milestone in any automation project. Here, detailed testing at the manufacturer or integrator helps to confirm that the automated system is in tip-top shape, individual components work together as intended, and everything is aligned with your documented functionality and technical requirements.
Several of your internal departments may be involved in the automation project, each with a different perspective. For example, while you concentrate on the science, a facilities manager may focus on the space in which the automated system will reside, and the IT manager remains chiefly concerned with connectivity. With multiple viewpoints and inputs, it’s no surprise that important details can sometimes get lost or miscommunicated.
Aligning on exact details, whether related to performance, quality, design, safety, and more, is why FAT is so critical to your long-term automation success. During the FAT process, it is possible to identify and address any potential issues before the equipment is shipped and installed in your facility. For instance, even a difference of two centimeters can disrupt the workflow on a table. Similarly, if the space is too much, it may hinder the robotic arm from gripping a microplate correctly, and if it's too little, it may affect the proper opening of a device door.
Testing may be performed as a dry-run (no liquid used) or with water. And, in cases where third-party devices are not yet available for integration, the control software may simulate that device to maintain virtual workflow continuity.
Prior to final installation, the equipment should also go through another key milestone called site acceptance testing (SAT). As the term implies, SAT at your site under your specific working conditions. While SAT and FAT both offer rigorous product and system testing, they are not interchangeable. For more information on SAT, read our blog, “How to Increase SATisfaction in Your Automated System”.
FAT offers four key short- and long-term benefits to maximize your workflow performance and minimize troubleshooting, costly delays, and unplanned downtime.
Automated technology manufacturers adhere to stringent internal criteria. FAT goes beyond this to account for your expectations and requirements.
During design and engineering, our engineers and your scientists agree upon system requirements. FAT is the final factory-based check to ensure that the requirements are met, the equipment is of high quality, and the system is functioning properly.
As we stated earlier, FAT can identify potential issues and manufacturing oversights while the system is still at the factory. Another example of a potential issue is an IT issue. Ethernet ports may be located too far from planned or actual room sockets. Testing at the manufacturer’s location means that system optimization, repairs, and enhancements can be immediately implemented. This is easier and less expensive, and involves significantly less risk, than trying to do the same after the equipment is installed in your laboratory. It also avoids downtime, unplanned expenses, and lost productivity on your part.
By identifying and addressing any possible issues during the Factory Acceptance Test (FAT), the system can achieve the highest level of performance possible within the limits of scientific laws. This gives the team a strong sense of confidence in the installed system, its components, and the analytical data it produces.
On top of performance and reliability, FAT can also help to improve safety. By identifying and correcting potential equipment or installation hazards, users and samples are protected from harm.
Identifying and addressing issues during FAT reduces unexpected expenditures on your part. This is because it is much less expensive to address issues identified during FAT at the manufacturer’s site than it is to do so after the system is installed in your facility. For example, imagine heading into installation of the automated system only to find out that it won’t fit into your new lab as the ceiling is too low. Fixing this would be a huge expense for you.
Pharmaceutical and life science companies are among the most heavily regulated markets in the world. And for good reason—the products developed and manufactured by these companies are intended to improve human health and wellbeing. Regulatory bodies like the U.S. FDA, EMA, and standards organizations such as ISO provide quality and safety frameworks to ensure that the products work as intended without causing harm to consumers. Failure to meet or comply with regulations could result in legal and financial penalties and can also negatively impact a company’s brand image.
Demonstrating compliance with these many guidelines requires copious and detailed documentation. This often includes proving that lab automation equipment is tested and validated prior to use with specific applications. Simulating these regulatory tests on your automated system during FAT can help to ensure that everything will run smoothly during actual validation tests. This helps to demonstrate that the system, including its integrated laboratory devices, will be compliant with guidelines.
You are investing thousands of dollars on automation. Your samples are invaluable. Your internal team has spent countless hours poring over project particulars. Executive management outlined their expectations. There’s a lot at stake.
You and your entire company need to build confidence in the automated system. A great place to start is with an automation partner that is experienced in delivering high-quality laboratory automation solutions. Solutions that not only fully meet their internal quality specifications, but also your rigorous requirements.
Automation partners that perform FAT provide you with peace of mind that they fully stand behind the automated system and are committed to investing time and resources to build and maintain your confidence in their work and your results.
You don’t have to risk time, money, compliance, and lots of unknowns on an unproven automated system. Instead, demand FAT!
HighRes Biosolutions has deep experience when it comes to detailed FAT on simple to complex automated systems. In fact, with our reputations on the line, we believe that FAT is in our best interests just as much as it is in yours. Contact us today to learn more about what goes into FAT and how to build a FAT checklist based on your unique requirements.
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