Hardware That Works: How to Choose the Right Tools for Your Life Sciences QMS and MES

Life sciences manufacturers are increasingly turning to modern quality management systems (QMS) and manufacturing execution systems (MES) to digitize their operations and improve efficiency. The ultimate goal of implementing modern digital manufacturing solutions is to reach digital maturity – a total adoption of the technologies that enable them to establish a seamlessly connected, optimized, and error-free operation. However, selecting the right hardware to support these systems is a critical and often overlooked step. Although life sciences manufacturers can feel overwhelmed by the variety of digital manufacturing solutions and hardware options put before them, the choices can be simplified with a targeted and systematic approach.

QMS/MES Digital Maturity Considerations

The first step to reaching digital maturity is to identify cleanroom validated hardware to mobilize your QMS and MES software. Using a Lean Six Sigma approach, life sciences manufacturing managers should take a critical look at their processes and map out how they are currently doing the job at hand. It is important to note the physical layout of their equipment relative to the workers and ask key questions such as:

• How many steps are they taking to reach the testing equipment and then how many steps are they taking to reach their workstation to input data?
• What happens if the data is entered incorrectly?
• How many steps are they taking to go back to the location of the process to gather the right data?
• How much time do I spend optimizing documentation for my hardware?

Tablets used as a tool in life sciences manufacturing may not always be the best choice of hardware. There is no doubt that using tablets to run digital manufacturing solutions has vastly improved mobility, however these devices have their limitations.

Firstly, battery health and flexibility must be considered. What happens to a production run if the tablet being used runs out of power? Will all data be lost? Battery health over the long term is also something to be seriously considered. How long is the battery in your tablet lasting? Can you make it through a complete shift without recharging? We all know that a tablet’s battery will degrade over time. How does your tablet stand up?

Secondly, using touch screens in a cleanroom environment is not ideal. Often cleanroom associates must wear two sets of protective gloves, and this can severely hinder their ability to use touch screens. The better solution is to use a mouse and keyboard for data entry.

Thirdly, tablet screens are smaller than traditional workstation displays and offer little flexibility. Take for example a cleanroom worker who must access his QMS for life sciences system to access work instructions and critical documentation and then move over to the MES for life sciences system to reference the batch record and complete data capture. If workers are clicking back and forth between applications, they are wasting time. And not having work instructions and batch records visible simultaneously can lead to human error. From an IT standpoint, batch records and forms may have to be optimized for use on tablets, creating extra man hours and increasing costs.

Finally, tablets are cumbersome. They must be held, and often there is no place to set them down in a manufacturing setting. Ideally, cleanroom workstations should have two monitors, a keyboard, a mouse, and be mobile, bringing all your technology to the point of task as this ROI study explains.

Choosing the Right Systems

So how do you identify systems that match your needs? Start by taking the following hardware considerations into account:

• First think about battery quality and backup systems. Ideally you want to choose a certified Lithium-Iron-Phosphate (LFP) battery system that has enough power to last a full shift and one that has a built-in backup system that ensures it will be up and running 24/7. This peace of mind can reduce deviations and the potential loss of inventory because if your system goes down, you lose data.
• Find hardware that matches the rigors of your environment. Cleanroom standards are rigid, and many hardware options won’t measure up. Cleanroom computer hardware should be designed to be easy to clean and disinfect. Enclosures must be made from stainless steel or medical-grade plastic that is antimicrobial and won't corrode from frequent use of cleaning agents. PCs must have cooling systems that are fanless, and all devices should have minimal crevices to reduce dust and particle buildup.
• Safety matters in any manufacturing facility and especially in a cleanroom environment. Battery safety, in particular, is something to pay careful attention to. Consider what can happen if you have the wrong type of battery in a cleanroom. Anything that can cause a fire is a hazard, and certain battery chemistries are prone to fire. Make sure you insist on Lithium-Iron-Phosphate batteries in your environment – they are the safest batteries available today.
• Move away from touch screens – they are difficult to use in a cleanroom that requires layers of personal protective equipment (PPE). Substituting a keyboard and mouse is a seamless way to enter data at the point of task, eliminating errors and enhancing productivity.
• Identify a hardware supplier that offers quality customer service. For your manufacturing operation to be efficient, you need to keep your equipment up and running 24/7. Make sure your service choice handles your repairs quickly and efficiently.

Benefits of Mobility

By having a mobile workstation, operators no longer need to walk to fixed stations to access digital manufacturing solutions. This streamlines workflow and enhances productivity, especially in a data-intensive cleanroom environment. With less motion waste you save time, enhance safety, and minimize deviations and human error.

Choosing the proper hardware is only one step in implementing a digital manufacturing solution. Choosing the right QMS and MES systems is another important factor, and we can help. Contact MasterControl and DTG for the advice you need to get your operation up and running quickly and efficiently.