Integrating FMEA templates and ISO standards directly into Jama Connect provides a comprehensive system of record to manage risk and help companies succeed amongst growing product development complexity
Jama Software, the leading development platform provider for building complex products and integrated systems, announced it has expanded Jama Connect™ Risk Management Center across regulated industries and platforms – both cloud and self-hosted. Until today, the capabilities were available exclusively for medical device companies using Jama’s cloud offering.
“From working with hundreds of customers in regulated industries, we realized that risks are requirements,” said Jama CEO, Scott Roth. “There are nuances in how risk is handled from industry to industry, but risk management is a core principle of product development, just like requirements. And when you bring risks directly into requirements management, they are much easier to control.”
Aerospace, automotive, semiconductor, and other industries are facing a growing risk management dilemma. Mistakes can endanger lives and permanently mar a company’s reputation. In addition, product safety regulations are getting stricter, and recalls are rising. At the same time, risk management can be cumbersome, frustrating, and inefficient. Many companies use multiple spreadsheets, paper records, or software that is ill-suited for risk management and requirements tracking, as well as for following industry standards such as FMEA and ISO 14971.
In a recent white paper, Frost & Sullivan noted:
“Legacy systems struggle to keep up with changing regulations, which can lead to compliance costs down the road. They can also introduce challenges with version control and be prone to errors. Due to their complicated functionality, legacy systems also inadvertently promote silos, forcing teams to prioritize the accuracy and timeliness of specific tasks in a way that can inhibit collaboration with other teams.”
Jama Connect Risk Management Center addresses these challenges by providing industry-standard customizable templates, enhancing collaboration, and offering a single system of record for risks and requirements. The platform also enhances risk analysis, giving teams stronger tools to identify and mitigate issues and move rapidly through the development process. Specifically, the center helps teams:
- Participate in risk assessment, including preliminary hazard analysis (PHA) and risk mitigation
- Incorporate FMEA and ISO 14971-aligned risk management templates
- Connect verifications to requirements
- Export plans for approval
“Risk management should not be siloed away from product requirements,” Roth added. “There must be a streamlined mechanism for all teams to work together towards common goals. We believe the Risk Management Center equips companies with the tools they need to identify mistakes before they become serious regulatory and reputational problems, and to develop successful, sustainable products rapidly.”
About Jama Software
Jama Software is focused on maximizing innovation success. Numerous firsts for humanity in fields such as fuel cells, electrification, space, autonomous vehicles, surgical robotics, and more all rely on Jama Connect™ to minimize the risk of product failure, delays, cost overruns, compliance gaps, defects, and rework. Jama Connect™ uniquely creates Living Requirements™ that form the digital thread through siloed development, test and risk activities to provide end-to-end compliance, risk mitigation, and process improvement. Our rapidly growing customer base of more than 12.5 million users across 30 countries spans the automotive, medical device, life sciences, semiconductor, aerospace & defense, industrial manufacturing, financial services, and insurance industries.