Making Life Easier for Quality Teams

Has your company implemented an Environmental Monitoring System (EMS), and now the support team is nowhere to be found? Oftentimes, when implementing an EMS, the end product isn’t as easy to use as it seemed in the demo, particularly when quality teams need to pull reports and audit logs to prove compliance. Whether it be slow response from support or inadequate training when learning the system, leaving quality teams without the ability to quickly get the data they need costs pharmaceutical companies valuable time and resources.

Switching to a new EMS can easily become a complex project, but it doesn’t have to be.

Switching Your Monitoring System

Making the switch to a new monitoring system can often seem daunting: revalidating your system, updating your SOPs, documentation, reporting, etc.… You need to understand why you want to switch your system before you make the move.

Maybe you want to switch systems because you’re forced to. Maybe your system is no longer supported, or it can’t scale with you as you grow. Scaling from R&D to clinical trials creates its own headaches requiring integration with new technology, sensors, system, hardware, animal housing, and a full company restructuring.

Some other common reasons your company may decide to switch your EMS include:

Your validated system has frequent issues that require lots of additional PQ work to be done (This is a huge drain on quality resources)
Lack of Scalability - The basic system you installed may start to have a lot of issues now that you have more endpoints - you need technical support to adequately grow your operation
Lack of support in learning the system or preparing for audits - Your initial user training may have covered basic functionality, but now you need to prepare for an audit and don't have anyone to support you

The reasons are countless, it’s critical to determine the challenges with your current system, and how a new system will alleviate them.

After determining the why of switching systems, it’s important to consider how your current needs will evolve over the next chapter your organization faces. Are you a GxP site, or expect to build one? If this is the case, you’ll need to navigate new factors such as validation, data security/encryption, and potentially 21 CFR Part 11 Compliance.

One service that most organizations will benefit from, or even require, is audit assistance. The GMP Audit Checklist shows the true scale of an audit. Audits for Pharma Production organizations can take upwards of three months to complete. With so many things to be on top of, selecting a managed service provider for your EMS can reduce your workload and ensure there are no mistakes. When it comes time to switch systems, quality teams should look to transition to Monitoring-as-a-Service.

The Case for Monitoring-as-a-Service

Monitoring-as-a-Service is the best solution for growing organizations because we provide you with a team of experts to manage all aspects of upgrading systems, a live 24/7 support team, and superior data accuracy with high-quality sensors. We’ll expand on each of these topics below:

Mitigate the Pain of Moving Systems

Working with a monitoring partner creates a relationship that ensures you’ll get the help you need from transitioning by:

Learning all about current challenges and goals. Understanding how the system affects all departments and what each group hopes to achieve - Lab, Facilities, Operations, & Quality.
Assigning a Design Engineer & Project Manager to your implementation - They develop design plans that can be reviewed with you and amended as needed.
Planning the physical implementation of the system - Professional installation technicians have daily check-ins to discuss work completed and plans for the next day. Amending as needed to work around the needs of a functioning lab.
Configuring software with the appropriate user access levels, alarm escalation protocols, and other settings.
Training your staff on the functionality of the new system. We offer an initial crash course on basic functionality and unlimited follow-up training for Super Users.
Validating your system (if needed) - Customer QA approves mature, audit-tested protocols and documentation paperwork. A XiltriX engineer performs IQ/OQ while documenting all results, providing you with a finalized packet at the end of this 3-day process.
Ensuring ongoing customer success via 24/7 support/service.

Hardware and Software Upgrades Included

Hardware - Repairs, replacements, and troubleshooting are all taken care of with a service partner - If you have a validated system, the necessary addendum paperwork is provided by XiltriX. No more dedicating internal IT or Quality resources to manage this.

Software - Bug fixes and patches come predictably, and at no cost, and all necessary addendum paperwork is provided for QA approval prior. When new features are released, you don't need to pay for these major upgrades or develop validation documents since they're provided by XiltriX.

24/7 Support & Service - The XiltriX SafetyNet Team

Monitoring-as-a-Service includes a live, 24/7 SafetyNet monitoring team that keeps a watchful eye over client systems to ensure alarms are never missed and that the system is always working. They’re here to support end-users with unlimited training and help reduce the pain of a Super User leaving your organization.

The SafetyNet team is also there as a second line of defense to make sure your team never misses alarms when parameters are breached.

All calls are recorded and automatically generate a ticket to create an immediate record of any event. Supporting information, such as system audit logs, sensor graphs, or emails, can be attached to this ticket to provide a crystal clear understanding of any historical events. This information becomes a detailed, accurate report that quality can review, sign off on, and include in any incident reports or quality management systems, as needed.

Here are some questions you may not have the answer to, but a service provider’s expert opinion can help you solve:

Why is my incubator taking so long to recover?
How do I integrate a backup generator into my EMS?
How should I monitor my HVAC?
What is clean room air testing?
How do I know if my fume hood has an acceptable airflow?
How do I know that my gas manifold switched tanks?
What’s the advantage of continuous particle counting?

This is why you need a partner who’s an expert in the industry and dedicated to monitoring. While many monitoring solutions are available, most vendors want to push all of the work and system management back onto the customer, leading to poor customer service and long support queues. Most researchers and scientists didn’t start a career in pharmaceutical drug development to be an expert in lab monitoring, and it’s likely not the key skill your company is recruiting for either. Why allocate valuable internal resources to manage your environmental monitoring system when you can leave it to the experts?

The Highest Quality Sensors

Working with a monitoring partner that manufactures its own sensors leads to many limitations. Typically, they will push for their sensor to be implemented, even if the quality of it is poor. XiltriX is a sensor-agnostic solution that provides the highest quality sensors in the market, whether it be temperature, humidity, particulates, etc. This, in turn, allows a holistic look at your equipment and environment that other solutions can’t offer. While one company may produce the highest quality CO2 incubator sensors on the market, they may not even offer an option for O2 monitoring.

There’s also the difference between integrating with sensors built into devices vs using third-party sensors placed through access ports. XiltriX can do both for virtually any piece of equipment, and while integration with the built-in sensors is cheaper, it has drawbacks.

Relying on the device to be working properly - If anything happens with the device functionality, you have no way of knowing where the issue is without third-party sensors.
In the event of a complete power failure, the monitoring system can no longer capture any data. This may mean throwing samples or products away because you don't know what happened during that downtime.
Accuracy of sensors in devices is lower than what independent sensors can provide. Better quality data means less variation in your science, more high-quality graphs/reports, and a faster time to market.

You should always be very aware of the sensors your monitoring solution attempts to bring in and understand how to recognize high-quality third-party sensors. You can do this by asking for spec sheets on all of your sensors so you can assess if they will be good enough for your application.

Another aspect to be aware of is the calibration of the sensors and how that plays into some QA activities. Do you need to send them out for a calibration, or can that be performed onsite? Data needs to be tied to a specific device, so sending a sensor out for calibration and using a spare in its place means you must ensure the data trail is complete and no mix-ups occur; otherwise, product/samples may be compromised. This can quickly become an administrative nightmare.

If a sensor is calibrated offsite, how do you know that it is the same calibration when it arrives back at your facility? If you ship them off, it can create a mountain of paperwork to track these changes and make it difficult to manage necessary addendums.

		`Monitoring-as-a-Service`
`1`	`Quality Control`	`- Compliant Audit Logs - NIST Traceable Calibration Offsets - Single platform from R&D through Manufacturing - Robust Reporting - Real-time Data Acquisition`
`2`	`Validation & Reporting`	`- Designed for compliance, QA/QC, audits, and validations - Provides IQ/OQ documentation, built-in reports, and an easy to use interface - Compliant with the highest standards`
`3`	`Support & Service`	`- SafetyNet team provides 24/7 live support and full system management - 30+ years of dedicated environmental monitoring experience - Industry experts`
`4`	`Compliant System`	`- FDA 21 CFR Part 11 Compliant - 99.999% Up-Time - Sensor and OEM Agnostic`

Conclusion

A lot of headaches for quality teams are caused when their environmental monitoring system isn’t up to their standards and they aren’t getting the support they need.

When it comes time to change systems, Monitoring-as-a-Service ensures an easy transition. Hardware and software upgrades are included, along with all necessary QA documentation, making it easy to stay up to date with the latest technology and keep your system running smoothly. High-Quality sensors create more reliable data to assist in audits, and sensors being calibrated in place reduces paperwork and improves reliability. With 24/7 service & support, you gain a second line of defense against missed alarms. Additionally, root-cause analysis and tracking creates a crystal clear log of events. Monitoring-as-a-Service makes it easy to switch. A professional team is there 24/7 to manage the whole project and ensure the new implementation is successful.

To learn more about how XiltriX can ensure your critical assets and equipment are protected 24/7/365, schedule a quick call to discuss how we support Quality Teams.

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How Monitoring-as-a-Service Makes Life Easier for Quality Teams