Validating the ServiceNow System For FDA Compliance

[johnfeist]

We are a medical device company and planning to start using ServiceNow change management.  Our compliance folks tell me that we need to validate ServiceNow before we can do that, per FDA regs.  In the past, when validating SaaS systems, we start with vendor documentation on how they validate the system before release.  I assume that to be an internal QA function.  I'm looking for information on where I can find documentation like that, or in the alternative how any other FDA regulated users have validated the system.

Thanks for any information you can provide.

John

[Mike Patel]

This might help

ServiceNow requires customers to first visit the ServiceNow Compliance Operations Readiness Evidence (CORE) for their questionnaire or assessment needs. If your customer does not have access to CORE, please continue reading below. If the customer has access, please refer to them to ServiceNow CORE: Directory of Topics and Documents for efficient access to an index of topics and direct links to documents about those topics. WHAT IS THE CORE The CORE is an extensive repository of ServiceNow documentation located in the ServiceNow Community where customers can find information about various regulations, standards, and internal policy. Updated regularly, the CORE includes: *Overview of the ServiceNow Quality Management System (QMS) *Overview of ServiceNow system architecture and security *Third-party attestations and audit reports *Key ServiceNow policies and procedures *Standard assessments and questionnaires WHO CAN GET ACCESS TO THE CORE CORE access is restricted to customer representatives in a regulatory compliance, audit, or security role. Partners and prospects are restricted to the Limited CORE. HOW TO GET ACCESS TO THE CORE A Community account and completion of a CORE registration survey is required to gain access to CORE. 1. Join the ServiceNow Community here: https://community.servicenow.com/login.jspa?registerOnly=true 2. Complete the ServiceNow CORE Registration Survey Access is role-based and dependent upon detailed responses to the survey questions. Please make sure you provide COMPLETE answers in the survey and avoid the use of abbreviations. It may take ServiceNow up to five days to grant you access to CORE. While waiting for access, we recommend that you read the e-book "Delivering Secure, Scalable, and Compliant Cloud Services" on the ServiceNow's Trust Site (https://www.servicenow.com/company/trust.html) for an introduction to security, privacy, and compliance program." 

[johnfeist]

Thank you Mike.  That's exactly what I need.

[johnfeist]

Hi Mike,

Answer was very helpful.  I do have one follow up question, where is the ServiceNow CORE Registration survey to be found?

Thank you,

John

[Mike Patel · Accepted solution]

here https://www.surveymonkey.com/s/FKY65D3

Groups > Special Interest Group>Join ServiceNow CORE^TM