Has Grand Avenue Been Certified to Any ISO Standards?

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.

• OneNeck IT Solutions is responsible for the physical security and cybersecurity of the data center. Documents describing their capabilities and certifications are available as noted in the table below.

• Grand Avenue is responsible for the security of the software application itself and the hosting environment infrastructure in the data center.

• Grand Avenue is responsible for backup and recovery of customer data in hosted installations. A document describing the technical details of that strategy is available to Grand Avenue customers upon request to support@grandavenue.com.

Additional details related to OneNeck IT Solutions are available as listed below.