Why the Way to a Hellish Quality System May Be Paved With Best Practices

Posted on Posted in Confluence, Electronic QMS, General, Training Genius PlugIn

Standard operating procedures (SOPs) created according to “best practices” ideally should lead to smooth, coordinated operations, greater productivity, lower risk of errors and better compliance. But oftentimes, the reality is different. Regulations and standards tend to be obscure and boring. The temptation to find a shortcut and skip bits of essential learning just to get […]

Two new things we love in Confluence

Two new things we love in Confluence

Posted on Posted in Confluence

The Atlassian tools and third-party plugins for Confluence are evolving all the time and at RadBee we’re always on the lookout for changes that might help to support your compliance and quality assurance needs. We’ve recently come across two gems. The first is a plugin that provides better control over reused content. The second is […]

Good practice dictates that controlled records should be managed in compliance with the FDA CFR 21 part 11 (aka Part 11) guidelines.

Adjusting Jira for FDA CFR 21 Part 11 compliance: managing deletion

Posted on Posted in JIRA

Regulations dictate that controlled records should be managed in compliance with the FDA CFR 21 Part 11 (aka Part 11) guidelines. Part 11 defines the criteria under which the US Food and Drug Administration ‘considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records […]

JIRA Service Desk can be used to manage customer issues in a way that will delight your auditor and your customer

Why Jira Service Desk can turn you into a hero

Posted on Posted in JIRA

Life sciences quality management procedures are often awkward. Dotted with their own strange lingo (observation, device master record (DMR), technical file, essential requirement etc), they can take some getting used too. Many seem to be designed with auditors in mind, rather than auditees, with a primary focus of demonstrating an intention to comply with regulations. […]

Comala workflow can be implemented to address FDA and other regulatory needs.

Using Comala Workflows for approval of controlled documents

Posted on Posted in Confluence, Electronic QMS, JIRA

When considering using Confluence to develop and release controlled documents, one of the main concerns many companies have is whether they will be able to approve the documents directly from the application. This is possible using Comalatech’s Comala Workflows plugin, which allows us to configure your desired approval workflow right into Confluence. This plugin has […]