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Brian Nye


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5 min read

Simplify FDA eSignature requirements in Atlassian Jira

By Brian Nye on Jan 22, 2019 11:40:00 AM

What is FDA 21 CFR Part 11?

FDA 21 CFR Part 11 regulation (Part 11) is the Food and Drug Administration's regulations that cover document signing and records retention for processes and documents specified by the FDA. Prescribed as an “open system” system solution, as defined in Section 11.3(b)(9), in which there is electronic communication among multiple persons and where system access extends to people who are not part of the organization that operates the system. The controls for an open system are discussed in Section 11.30.

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3 min read

How to Extinguish Fires with Jira Service Desk Automations

By Brian Nye on Aug 27, 2018 11:00:00 AM

While service desk agents do everything they can to avoid firefighting, they are often focused on extinguishing one fire and moving to the next. This usually causes tickets to smolder in some status of "not quite done" until months later when they will finally be closed out (thanks bulk edit!). The good news: there is a way to keep things moving using out-of-the-box functionality. No longer will your metrics be inaccurate because people aren't "moving their tickets through the system." Jira Service Desk can help do the moving for you with automation.

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