fbpx

Blog

How to Achieve FDA CFR 21 Part 11 Compliance

How to Achieve FDA CFR 21 Part 11 Compliance

If you are in digital health or clinical research, you’ve likely heard about FDA 21 CFR Part 11 compliance. (Or, if you are on friendly terms, simply “Part 11.”) This regulation is unclear and confusing, which can complicate compliant implementation — especially for Jira users.  Because we’re dedicated to helping you sleep well at night, here’s a simple, no-nonsense survival guide for Part 11. While it does not replace any full-blown legal or regulatory advice, it should help you understand the gist and set your company up for success.  You’ll also be able to check out a real-life example...

read more
Signing off on Jira: Adobe Sign can help you sign off.

Signing off on Jira: Adobe Sign can help you sign off.

Why sign Jira issues with Adobe Sign? When it comes to signing off on Jira Cloud issues, you have a lot of options. We’ve written a comprehensive guide on all the different options. From our article on signing with DocuSign to the quickstart on using our own Speedy PDF Sign Offs. We’ll take you through the process of signing  off using Adobe Sign, one of the leading eSignature apps on the market. Step 1: Getting Started with Adobe Sign Like many apps, Adobe Sign lets you try before you buy. You can experiment with it by starting a seven day free trial on their website. Step 2: Creating an...

read more
4 Ways Speedy External Storage Can Improve Your Workflow

4 Ways Speedy External Storage Can Improve Your Workflow

See how Speedy external storage protects you from data loss and keeps Speedy free. The Speedy PDF App is used to sign off on Jira Issues, help your team move quickly, and stay on task. However, the app relies on a connection to an external storage location to operate, which can be a headache to configure. We’ll explain here four reasons why we chose to make storage for Speed-eRecords one of the core features of our App: Speedy’s external storage saves signed-off Jira issues for compliance audits. External storage protects your data from accidental deletion. Speedy stores your data in your...

read more
Life science companies and the Atlassian Cloud? Survey results

Life science companies and the Atlassian Cloud? Survey results

Check out our Atlassian Cloud Survey results Atlassian is retiring their Server offerings. Now pharmaceutical industry figures who rely on Jira Server will need to plan for the future. To get a sense of how the pharmaceutical industry is responding to the upcoming changes, we conducted a survey. In this article you can inspect our Atlassian Cloud survey results in which we asked players in pharmaceuticals and the life sciences whether they were planning on making the switch to Cloud.  How eager are pharma companies to move to Cloud? Figure 1. Are you switching to Atlassian cloud? Figure 2....

read more
Password Protection and OTPs, authenticating your eSignature

Password Protection and OTPs, authenticating your eSignature

The importance of your electronic signature's password protection Like all eSignature apps, Speedy PDF Sign-Offs is designed to replace your wet signature on legal documents. Without them, signing off on issues is a chore of printing a document, signing, scanning and sending. eSignatures are a powerful tool in making signing off on issues easy. However, with power comes risks. An eSignature has the full legal weight of your handwritten signature. That means protecting your electronic signature is just as important. In this article we will clarify how and why your eSignature is legally...

read more
Keeping Speedy Secure with the Atlassian Bug Bounty Program

Keeping Speedy Secure with the Atlassian Bug Bounty Program

Find Out How The Atlassian Marketplace Security Bug Bounty Program Protects Speedy PDF Sign-Offs Speedy PDF Sign-Offs is a Jira App for official document sign-offs. It keeps teams running at their best pace by allowing them to sign documents in Jira. No need to go through the circus of printing, scanning and routing. Now RadBee is going the extra mile to enhance Speedy’s stability and security. RadBee has submitted Speedy to the Atlassian Bug Bounty program to guarantee that you have the best product possible. What Is The Bug Bounty Program? The Bug Bounty program is one of Atlassian’s...

read more
Will Speedy Remain a Free eSignature App?

Will Speedy Remain a Free eSignature App?

I got a message on our service desk the other day. It was from a Speedy customer, Carla, a compliance analysis-specialist. She told me that whilst she liked Speedy and it’s features. Like other Jira users she uses it for compliance audits. Yet she was suspicious of the lack of a price tag as a free eSignature App. Dear Rina, I want to know if you plan to keep the Speedy App free. I just want to make sure that I’m not surprised by a payment or subscription bill at some point down the line. Carla was concerned that Speedy, for all it’s features, was too good to be free. She was concerned that...

read more
How to Sign Jira Issues with DocuSign

How to Sign Jira Issues with DocuSign

DocuSign is one of the leading eSignature apps on the market. You may already be familiar with it and want to use it to sign Jira Issues. However, since DocuSign isn’t natively compatible with Jira Cloud, there are steps you to go through to use it to sign Jira Issues with DocuSign. We’ll show you how to bridge that gap and use DocuSign to sign issues from Jira Cloud. Step 1: Getting Started with Docusign. Getting started with DocuSign is much like trying out any new app. You can experiment with it by starting a free trial on the website, here. Step 2: Creating an Account. To use DocuSign,...

read more
Prepare for compliance audits with the newest eSignature App

Prepare for compliance audits with the newest eSignature App

Speedy PDF Sign-Offs for Jira Cloud by RadBee is an eSignature App designed for fast-paced teams in regulated industries. It addresses situations when you need to create legal records from Jira Cloud issues to prepare for compliance audits.  Auditing Many of Speedy’s users are concerned about compliance audits. Preparing for an audit and making your records look ship-shape can take up a lot of time and energy. With Speedy PDF, all the signed issues are automatically stored for long term archiving. Even if the original issue is deleted or lost, the copy remains. This feature is indispensable...

read more
Quick Start Guide to Speedy PDF Sign-Offs

Quick Start Guide to Speedy PDF Sign-Offs

Step 1 – Getting Started with Speedy PDF Sign-Offs Getting Speedy PDF Sign-Offs rolling is a breeze. The App is available for free on the Atlassian Marketplace. It takes minutes and a couple of clicks for an admin to download Speedy to your Jira Cloud. You then connect it to a central storage location such as a google drive. The storage location is important since it makes the signed Speed-eRecords available for audit, even if the Jira issues have since been deleted. Connecting a storage location is very simple, especially if you choose to use a google drive.  For a quick experimental setup,...

read more