Pharmaceutical companies are in a hurry to adopt agile software development practices. It's a massive trend seeing companies forcing teams to climb the agile train....
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Posts about: Capa
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...
Use Jira to Document Meetings, So You Can Focus on What Matters
Quality Assurance processes often require holding reviews and documenting decisions made by stakeholders. Common examples include CAPAs Review Board, Complaints Review...
Why you should manage requirements in Jira
This post was updated on May 2021. It now relates to all Jira variants: Cloud, Server and Data Center. What's the difference between Jira and Confluence? Many of my...
Compliance, usability and culture in quality management
The biggest challenge in building a quality management system (QMS) is accommodating the needs of both compliance inspectors and your team. However this is a challenge...
Improving your CAPA SOP with Jira – an action plan
Quality management and improving your CAPA SOP. This post outlines the steps involved in setting up a quality management system (QMS) process in JIRA Core. QMS standard...
Why should quality assurance be difficult and awkward? Take a strategic view on achieving compliance (focus on ISO 13485)
It is all too easy to dive into the list of requirements contained within the ISO 13485 and achieve compliance by just ticking the boxes: looking at one requirement or...
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