How Strong Design Controls Simplify Compliance and Eliminate Audit Anxiety

The Benefits of Connected QMS

Connected QMS

With Arena QMS, a DHF can be easily created from predefined templates that adhere to your established SOPs and broader quality system framework. This ensures consistency and control and links quality and design from the very start. Having these elements linked streamlines compliance and allows you to easily demonstrate that your products and processes meet regulatory requirements.

The benefits of connected quality and design also extend throughout the entire supply chain, mitigating challenges created by dispersed partners and teams that span multiple time zones and locations. Centralizing the BOM, DHF, and DMR along with associated product design and quality system records keeps everyone on the same page to reduce confusion and costly mistakes.

Adopt a Better Approach to Meet FDA Design Controls

With Arena’s product-centric QMS solution, medical device manufacturers can achieve and maintain regulatory compliance by bringing quality, product, and all teams together in a single connected QMS solution. This gives key stakeholders in quality assurance and regulatory compliance the confidence to address internal and FDA audits anytime. To learn more about how Arena QMS can help your company streamline NPDI processes and streamline compliance, contact Arena today.