Stelex, a firm providing enterprise wide compliance solutions to the regulated industries and MRO Software a provider of strategic asset management solutions, have announced an alliance to provide risk-based, integrated, cost-effective compliance solutions for industries regulated by the U.S. Food and Drug Administration (FDA).
Through this alliance, the two companies will provide a complete solution for FDA regulated customers based on MRO Software’s strategic asset management solution, MAXIMO( 5 Pharmaceuticals and Stelex’ Common Sense ComplianceSM Approach. The combination of Stelex’ domain expertise and MRO Software’s services and solutions will help customers implement solutions to improve business processes and help to meet the regulatory requirements of the life sciences and other industries regulated by the FDA.
“Regulatory bodies, such as the FDA, are redesigning the compliance landscape through the use of Risk Based approaches. These changes have a significant impact on the implementation of asset management at pharmaceutical and medical device companies” said Daniel R. Matlis, vice president, business development at Stelex, “The combination of MRO Software’s Strategic Asset Management solutions and Stelex’s Common Sense Compliance approach will allow clients to implement cost effective, risk-based solutions that meet regulatory requirements and benefit the bottom line.”
This alliance builds on the strong presence that both MRO Software and Stelex have within the pharmaceutical industry. MRO Software currently provides asset management solutions for the world’s top 13 pharmaceutical companies.
“The FDA and other regulatory bodies are constantly updating their regulatory requirements which have an impact on how assets are managed across the enterprise,” said Johan Arts, director, industry marketing at MRO Software. “Together with Stelex, we monitor the changes in the regulations very closely. We then have processes in place to evaluate the impact of changes on our services and solutions. By closely monitoring enforcement trends we can respond swiftly to changes required to our offerings and deliver these improved solutions to our customers.”
