When teams set out to determine the requirement specifications for a computerised system, confusion often arises. However there are some simple steps you can take that...
Requirement specifications
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Posts about: Risk management
Risk analysis for computerised systems
When done correctly, risk analysis can help to identify things that could go wrong in a process once it has been put into action. It may also trigger creative thinking...
How to manage requirements and risk analysis in Jira
Managing requirements and risk analysis in Jira This is an updated version of the post: “risk analysis in Jira.” It relates to all Jira variants: Cloud, Server and Data...
When does a software tool require validation?
If a software tool is used for any process that affects product or quality systems in a regulated sector like life sciences - pharmaceuticals, medical technology or...
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...
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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