Ensuring Regulatory Readiness for Life Sciences Leaders
SIMCO is excited to announce that the company has been named a Top 10 Life Sciences Compliance Solutions Provider by Life Sciences Review Magazine.
For over 60 years, SIMCO Electronics, Inc. has been the forerunner in providing lean quality and compliance expertise, software, and services to manufacturers in the life sciences, aerospace, defense, and other highly regulated industries. Initially founded out of NASA to provide calibration and repair services for test and measurement equipment, today SIMCO has expanded its offerings to include a full suite of regulatory cloud software and services that its customers use to manage the quality and compliance of lifesaving equipment, people and programs.
SIMCO’s industry leadership is built on its 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. In addition to its industry expertise, half of SIMCO’s employees have Lean Six Sigma training. “We don’t compromise on quality, and we lead by being lean,” says Sam Klooster, Vice President of SIMCO’s software business. “At the heart of our mission is the understanding that our customers’ equipment is used in the most demanding environments to protect the lives of patients, soldiers and loved ones.”
SIMCO’s decades of experience in industries that answer to multiple regulatory bodies, such as the FDA, ISO and CLIA, give the company firsthand insight into its customers’ unique challenges. To demonstrate regulatory compliance, these manufacturers need clear visibility into how and where each asset is used, maintained and serviced. They also must ensure that the systems used to manage quality are compliant with the FDA’s 21 CFR Part 11 and Part 820 regulations. Many struggle with error-prone manual processes that make it difficult to respond effectively to internal and external audits, and to share information across multiple locations.
SIMCO cuts through the layers of these challenges with its fully integrated suite of CERDAAC cloud solutions and services, which help quality and operations program managers drive operational excellence, minimize equipment downtime and prove compliance. In fact, many SIMCO customers implement CERDAAC to address an urgent CAPA or quality challenge not addressed by their current system or software. Managers can also use CERDAAC to identify out-of-tolerance (OOT) equipment and its location on the production floor. Using CERDAAC, SIMCO clients have gained, on average, a 287% ROI in business value.