SIMCO Electronics
CERDAAC CMMS Helps Highly Regulated Life Sciences Manufacturers Deliver Lifesaving Quality, Leaner

For over 60 years, SIMCO Electronics, Inc. has helped manufacturing leaders in the life sciences and other highly regulated industries to efficiently service and manage equipment, tools, and other critical assets, which produces lifesaving products and services. Aside from SIMCO’s expert calibration and repair services at labs across the country, the firm’s customers use CERDAAC—the company’s award-winning CMMS software—to increase the efficiency, quality, and accuracy of their asset management processes. Subsequently, SIMCO clients using CERDAAC have gained approximately 287% ROI in business value.

The CERDAAC software is built on SIMCO’s decades of expertise delivering over 15 million services to more than 3,000 highly regulated customers, including 16 of the top 20 global life sciences companies, such as Abbott, GE, Myriad Genetics, WuXi AppTec, and STAAR Surgical.

“With CERDAAC, WuXi AppTec now has the documentation it needs to provide to regulators and clients. We’ve mitigated our regulatory risk by utilizing SIMCO CERDAAC software and making that workflow an electronic one.” – WuXi AppTec
As highly regulated manufacturers, SIMCO’s customers are typically challenged to comply with a wide range of both internal quality standards and external regulatory requirements. That means that hundreds, and even thousands, of assets used in production must be precisely calibrated, meticulously maintained, and promptly serviced. Every time an asset is introduced, moved, or serviced, these processes must be extensively documented to prove compliance for both internal and external auditors.
At the heart of this operational mission are the calibration technicians, maintenance engineers, and facilities managers who ensure each piece of equipment is managed by industry standards. They must respond swiftly and efficiently to both internal and external audits. They must also ensure that the systems used to manage quality comply with the FDA’s 21 CFR Part 11 and Part 820 regulations.

“Manufacturing’s unsung heroes are the operations teams, these skilled experts meticulously calibrate and maintain thousands of tools, ensuring production readiness, yet their pivotal role often goes unrecognized,” says Sam Klooster, VP of Software at SIMCO

Until recently, most technicians had to manage these critical functions relying on a combination of paper, spreadsheets, and legacy software. Duplicate copies of paper records, missing data, and physical signatures made asset management processes labor-intensive and prone to errors. Subsequently, compliance with regulatory standards was time-consuming and difficult, often putting the organization at risk for events, such as FDA warning letters and CAPAs that can impair production and product quality.

To help these unsung operations heroes do their jobs more efficiently and effectively, SIMCO introduced its award-winning CERDAAC suite of Asset Management clouds. SIMCO customers use CERDAAC to digitalize and streamline their calibration, maintenance, facilities management, and other quality processes. In fact, many SIMCO customers implement CERDAAC to address urgent CAPA or quality challenges not addressed by their current system or software. The results include reduced production downtime, improved compliance, and streamlined regulatory and internal audits.

“After our initial evaluation of CERDAAC, we realized it was the only solution we had found on the market that would help us meet our needs and the new, more stringent FDA requirements.” – PHARMACEUTICAL INDUSTRY LEADER

CERDAAC, a blend of traditional Computerized Maintenance Management System (CMMS) and Enterprise Asset Management (EAM) capabilities offers cloud solutions for managing crucial assets and programs integral to production. Its core CMMS solutions include Calibration Cloud, Maintenance Cloud, and Facilities Cloud. Recently, SIMCO has expanded its offerings with the introduction of new cloud solutions. These include the Enroll & Control Cloud, Workforce Cloud, Partner Cloud, and Product Traceability Cloud, further enhancing its comprehensive asset and program management suite.

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“With CERDAAC, we are able to prove full compliance with all of our regulatory requirements, including our staff’s licenses and permits, as well as our equipment.” – SIMCO CUSTOMER Prebuilt workflows make it easy for customers to get started using the software, while CERDAAC’s automated notifications and e-signatures help keep everyone on track. Intuitive reports and dashboards assist program managers in keeping tabs on equipment service histories and proactively schedule services.

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CERDAAC’s cloud architecture makes it easy for customers to purchase, implement and maintain while minimizing any IT burden. Users access the software online through a subscription, with no on-premise hardware or software installation required. Upgrades and updates are also automatically applied and managed by SIMCO. And because every client’s business processes are unique, CERDAAC is highly and easily configurable, using “clicks, not code,” to adapt the software to the customer’s unique business needs.

Another significant advantage for CERDAAC customers is that the software is prevalidated to meet the FDA’s 21 CFR Part 11 and Part 820 regulatory standards. Unlike many software providers that offer extensive documentation that clients use to validate their own systems, CERDAAC is prevalidated out of the box for its intended use, saving clients significant time, resources, and expense. For more in-depth customizations, SIMCO’s CERDAAC experts also provide hands-on, in-person training and support.

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With decades of experience working with highly regulated manufacturers, SIMCO is the ideal partner for life sciences manufacturers being challenged to deliver lifesaving quality, leaner.