Standards and compliance
The Qity apps support the quality-management standards used in regulated industries. This page lists which ones, links to each standard at its source, and is direct about the part that is yours rather than ours.
Standards the apps support
Each app names the standards specific to it on its own overview page. The list below is the set the suite as a whole is built around.
| Standard | What it covers |
|---|---|
| ISO 9001:2015 | Quality management systems, in any sector. The general standard the others build on. |
| ISO 13485:2016 | Quality management systems for medical devices, written for regulatory purposes. |
| ISO 14971:2019 | Applying risk management to medical devices, across the whole product life cycle. |
| IEC 62304:2006+A1:2015 | Life cycle processes for medical device software. |
| FDA 21 CFR Part 11 | Electronic records and electronic signatures, as the US FDA requires them. |
| GxP | The good-practice regulations in life sciences, covering manufacturing, laboratory and clinical practice. An umbrella term rather than a single standard, so there is no one document to link. |
Configured correctly, the apps support compliance with the standards above. They do not deliver it on their own. A compliant system is the combination of the software, how you configure it, the procedures you write around it, and the validation you perform. That last part stays with you, and no vendor can do it for you.
Electronic signatures
Every approval across the apps is signed with a one-time password sent to the approver’s email address. Entering it ties that approval to one identified person at a recorded time, which is what gives the record an attributable electronic signature rather than a name in a field.
Configured correctly, that supports compliance with FDA 21 CFR Part 11. The configuration matters: see each app’s admin page for what has to be in place, and Set up your account for the email setting the signature depends on.
Where the records live
Quality records are native Jira work items and controlled documents are Confluence pages, so the audit trail is the one Atlassian already keeps, not a second one inside a Qity database. How Qity works explains the split and why it matters for traceability.
AI management systems
ISO/IEC 42001:2023 is the management system standard for artificial intelligence. It sits in a different domain from the standards above, which is why it is listed here rather than in that table: those cover quality management, this covers AI governance.
Qity configures an AI management system aligned to ISO/IEC 42001, built the same way the apps are, with records held as native Jira work items. It is the system Qity runs itself, and it can be configured for your site too. The caveat above applies unchanged: a configured system supports compliance, it does not deliver it.
The AI management system is configured rather than installed, so it is not on the Atlassian Marketplace and there is nothing to download. Packaged apps for ISO/IEC 42001 are in development, with no release date set. To ask about the configured system, email info@qity.be, which reaches the team directly rather than the support portal.