Environmental Monitoring Systems (EMS) should reduce work for quality teams, but often new systems leave teams adrift without adequate support at implementation. The end product can be more difficult to use than it seemed in the demo, particularly when quality teams need to pull reports and audit logs to prove compliance.
Implementing a new EMS can easily become a complex project, but with the right support, it doesn’t have to.
When should quality teams consider a new environmental monitoring system?
The decision to change the lab’s monitoring system is not trivial and should be carefully evaluated—to start, doing so will mean revalidating the system and updating SOPs, documentation, and reporting. What are the challenges the lab currently faces, and how would a new system address them? There are several common problems labs encounter for which moving to a new system offers the best solution.
- Drain on Quality Resources: A validated system that has frequent issues requires a lot of additional performance qualification work.
- Lack of training support: Labs often find themselves on their own when it comes to training after installation or for more complex workflows, and are left struggling at audit time.
- Lack of system support: Maintaining the system is also a large job, particularly when it comes to keeping hardware and software updated and navigating troubleshooting and repairs.
- Lack of scalability: A system that can’t scale with growth, for example, from R&D to clinical trials, creates headaches when labs need to integrate new technology (sensors, systems, or hardware), restructure teams or roles, and introduce new areas to monitor, like vivariums. Adding more endpoints can create problems in basic systems, creating a barrier for labs lacking adequate technical support to scale operations.
Next, it’s important to consider how needs will change with evolving operations. For example, when building a GxP site, labs need to navigate new factors such as validation, data security/encryption, and FDA 21 CFR Part 11 compliance.
Most labs benefit from audit assistance. Audit preparation is a massive undertaking—as shown by the GMP audit checklist—and can take up to three months to complete in pharma manufacturing. A managed service provider for EMS reduces the workload considerably. They can also ensure successful adoption of the system for companies without the in-house expertise to design, install, and maintain an EMS.
How to ensure an easy transition to a new lab environmental monitoring system
A lab monitoring partner that offers comprehensive support smooths the transition to a new monitoring system considerably. Use this checklist when looking for a service partner to ensure you will have the assistance you need.
EMS service provider support checklist
- Understanding of current challenges and goals: A partner should proactively learn how the system affects the lab, facilities, operations, and quality departments and what each group hopes to achieve.
- Assigned design engineer and project manager: A monitoring service will work with the client to develop design plans that meet all needs.
- Detailed plans for physical system installation: Installations take time and can be disruptive if not properly planned and executed. Daily check-ins with lab staff to discuss work completed and plans for the next day are needed to accommodate the needs of a functioning facility.
- Ongoing hardware support: Hardware upgrades, repairs, and troubleshooting can become costly and time-consuming if not covered. They also require addendum paperwork for validated systems. A service provider can remove the load from the IT and quality teams' shoulders.
- Environmental monitoring software configuration: Software needs to be configured with the appropriate user access levels, alarm escalation protocols, and other custom settings.
- Software support: Does the service provider include software updates for patches, bug fixes, and new feature releases, or is that an additional cost? How about the addendum paperwork?
- Staff training: Labs should expect initial training on basic system functionality with unlimited follow-up training.
- System validation: A partner should provide mature, audit-tested protocols and documentation paperwork for QA approval. They should also have an engineer perform installation qualification (IQ) and operational qualification (OQ) and provide a final report documenting all results.
- Live around-the-clock support: Labs should have 24/7 customer service with dedicated and experienced live agents to ensure ongoing success.
Additional considerations for choosing an environmental monitoring service partner
Environmental monitoring sensor quality
Environmental monitoring services that manufacture their own sensors carry limitations. They will typically push for their sensor to be implemented regardless of sensor quality and market alternatives. XiltriX is the only sensor-agnostic solution. This approach enables quality-based sensor selection—ensuring only the highest quality sensors on the market for temperature, humidity, particulates, etc., are deployed—and provides a holistic look at equipment and environment that other solutions can’t offer.
Rapid, expert service response
To be effective, a monitoring partner must be specialized and committed to monitoring. Researchers and scientists are not lab monitoring experts and cannot vouch for quality control or assurance standards.
When you are in the market for a support team, be sure to ask what the average ticket response time is. Waiting on hold for hours with a concern that needs to be addressed is frustrating, wastes time, and leads to lost productivity. With an average response time of under 30 minutes and an overall Service Level Agreement of 2 hours or less, the XiltriX SafetyNet Team is quickly reached by phone call, email, or ticket submission. The 24/7 live monitoring team maintains a constant watchful eye over the facility and is present on every alarm protocol to ensure the system is always working and alarms are never missed.
Quality teams need a detailed, accurate report from the service provider that they can review, sign off on, and include in any incident reports or quality management systems. At XiltriX, 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, forming a comprehensive report.
The industry expertise brought by an experienced service provider enables them to answer the many questions that arise around environmental monitoring, such as:
- 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?
Why Choose XiltriX
When it comes to changing laboratory environmental monitoring systems, Monitoring-as-a-Service ensures an easy transition. XiltriX provides hardware and software upgrades along with all necessary QA documentation, making it easy to stay current with the latest technology and keep your system running smoothly. High-quality sensors create more reliable data, assisting with audits, and calibrating sensors in place reduces paperwork and improves reliability.
With access to 24/7 live agents, you gain a second line of defense against missed alarms. Additionally, root-cause analysis and tracking create a crystal-clear event log. A professional team manages the whole project around the clock and ensures the new implementation is successful. Monitoring-as-a-Service makes it easy to switch.
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.