BUSINESS CHALLENGES
With an approximately $20M contract from the U.S. Army, SIONYX launched a product program that required not only the team’s innovation and technical competence but also control of all technical data and design for government regulatory compliance. “We needed to demonstrate that we have a formal set of industry-standard controls around how we do things and how we manufacture,” stated Steve Anderson, Vice President of Operations for SIONYX. “We had manual processes early on and our government customers required us to implement a PLM system with embedded best practices and automated workflows—aligned to ISO9000 standards.”
The defense contract brought SIONYX the compliance requirement for proper handling of technical data, including access controls, full audit history, and a compliant platform architecture. Arena’s AWS GovCloud platform solution provided a low-overhead solution for SIONYX to meet the business and regulatory needs with significantly reduced risk.
An additional hurdle to the project was time, or lack of it. “We kicked off this project in January and we needed to demonstrate to the government by August that we had a compliant setup between QMS and document controls,” shared Anderson. “We had a very tight timeline.”