Ensuring your production line and facility operate smoothly requires keeping track of many moving parts at once. Every bit of unplanned downtime must be mapped back to the budget as each inspection, audit, and upgrade is tracked manually or, more often, across several siloed systems. Failure isn’t an option, but it’s unfortunately inevitable with information so widely dispersed and the sheer volume of variables at play.
Shifting from a reactive to a proactive maintenance strategy is a must, and a CMMS (Computerized Maintenance Management System) makes this possible.
A (CMMS) aggregates information from all your siloed systems so maintenance managers and other operations professionals can track, maintain, and manage vital production-related assets. They can also schedule services—all in one place.
With a CMMS as the foundation, the focus will shift from responding to unplanned maintenance challenges and missed timelines to tracking scheduled services that minimize downtime and optimize asset and personnel allocations. And it’s something leading medical devices, pharmaceuticals, biologics, aerospace, and defense manufacturers are rapidly adopting because it’s purpose-built specifically for their needs.
Predictable & Purpose-built for Regulated Manufacturers
Asset management is both a top priority and a top challenge for most medical devices, pharmaceuticals, biologics, aerospace, and defense manufacturers—and we are intimately aware of how this environment looks.
Our customer base includes 3,000 of the world’s largest highly regulated industry manufacturers who depend on our software to automate accountability and maintain regulatory compliance. It’s a series of functions that require very specific expertise.
The process of identifying, documenting, and maintaining the vital equipment used in the production of life-saving medical devices comes with significant long-term costs—costs that are avoidable with the right management software powering your efforts.
Asset management software can simplify and streamline workflows, reducing errors and duplicate records. However, the solution(s) that most medical devices, pharmaceuticals, biologics, aerospace, and defense manufacturers already have in place fall short of a CMMS on all fronts, particularly as many rely on Excel spreadsheets and in-house databases.
Traditional “automations” range from siloed stopgaps that have been used for years to outdated programs requiring manual interventions. All are plagued by input errors that could and should be taken care of with more sophisticated technology, but there’s a disconnect with decision-makers. They’re unclear as to how a CMMS changes a manufacturer’s operations and what is the ROI of it all?
The ROI of CMMS-powered On-time Compliance
Keeping your operation ahead of potential CAPA (corrective and preventative action) findings and improving overall compliance is mission critical. Instruments overdue for calibration create risks for not only regulatory compliance but also product quality and safety—all of which come at a substantial cost.
It’s no surprise that the best-in-class manufacturing programs have >99% on-time compliance, and this does not happen by chance.
Manufacturers often overcomplicate the process with measurement calculations we break down here that are often used in isolation, when they should be used concurrently and in addition to other methods. Combining a snapshot in time data with information captured using the defined timeframe methodology just makes sense and ensures a more complete operational understanding.
Calibration programs with the worst on-time compliance rates are typically manually managed or technologically disjointed with some combination of paper and spreadsheets. It’s slow, labor-intensive, and prone to errors. And errors are costly.
A CMMS, on the other hand, saves costs that can be reallocated away from administrative burdens, report discrepancies, and instrumentation errors that can significantly impact operations and safety. It offers an accurate and up-to-date database of all instruments and their service information in real-time with both snapshot and defined timeframe methods captured, creating a single source of truth to track overdue items. And it can be sorted by department and shared with the responsible managers via reports and dashboards.
It’s an intelligent, cloud-based operations compliance platform that can automate and coordinate all calibration, maintenance, validations, and other essential processes, ensuring compliance with greater efficiency and less downtime.
Meeting complex regulatory requirements happens quicker and with much greater accuracy when manufacturers have automated service due notifications capable of sending escalating reminders. This ensures that persistent problems are eliminated. Daily production checks can even be sent for instruments that cannot afford a single overdue instance. And it can remind organizations with distributed field service teams to send out replacement instruments in advance of calibration due dates.
A CMMS is highly configurable and scales to adapt to evolving processes and regulations, creating a culture of continuous improvement that offers significant ROI on its own
Creating a Culture of Continuous Improvement
With the medical devices, pharmaceuticals, biologics, aerospace, and defense manufacturing industries undergoing massive shifts in the way products are made, tested, shipped, and sold, regulated manufacturers are increasingly adopting tenets of continuous improvement to guide operations.
This makes sense, as environments adopting these tenets experience:
- Improved product and service quality
- Greater efficiency and productivity
- Increased employee engagement and retention
- Greater customer satisfaction and loyalty
Ultimately, increased profitability is the end result, but it is not a foregone conclusion. Manufacturers successfully adopting a continuous improvement mindset start with CMMS software that supports this change.
Too many traditional software applications act as an inhibitor rather than a facilitator of change though, merely creating an additional item on an already extensive list of siloed applications, and it’s important to know which is which. We’ve detailed the differences between these growth accelerators and inhibitors in this continuous development white paper to help you select software that strengthens your compliance efforts and supports your cultural shift.
Reach out to learn more and see our best-in-class CMMS in action, and in the meantime, check out this piece detailing the potential and pitfalls of digitalizing your operations’ quality processes. In it, we’ve shared key learnings from hundreds of software deployments with global manufacturers in the life sciences, aerospace, defense, and other highly regulated industries.
