Grand Avenue has not been certified to any ISO standards.
Quality System Standards
As a provider of quality management system software (which is not classified as a medical device) Grand Avenue Software follows ISO 13485:2016 and 21 CFR 820 in the areas where it is applicable to our organization and manages those quality system processes using our own software. Grand Avenue’s quality manual describes how the company’s practices voluntarily align with medical device quality system requirements and is available to Grand Avenue customers upon request to support@grandavenue.com.
IT Standards (applicable to hosted customer installations)
Hosted customer installations are located in the OneNeck IT Solutions data center in Eden Prairie, Minnesota.
Grand Avenue provides the framework that deploys and maintains customer installations in the hosting infrastructure.
OneNeck is responsible for the privacy, physical protection, and cyber security of the hosting infrastructure. They are certified to ISO/IEC 27001:2013 Information security management systems.
Grand Avenue is responsible for backup and recovery of data in the hosting environment. A document describing the technical details is available to Grand Avenue customers upon request from support@grandavenue.com.
Additional details related to OneNeck IT Solutions are available as listed below.
OneNeck IT Solutions Information | Where to obtain a copy |
|---|---|
OneNeck Compliance | Download from OneNeck website |
OneNeck Data Center in Minneapolis, MN | Download from OneNeck website |
OneNeck Data Centers Overview | Download from OneNeck website |
OneNeck Type 2 SSAE 18 (SOC 1 and SOC 2) Reports | Available on request from support@grandavenue.com. A signed non-disclosure agreement is required for access to this information. |
OneNeck Certificate: ISO/IEC 27001:2013 Information security management systems | Available on request from support@grandavenue.com |