Thanks to Laurence Sampson for writing this article, as a preview to the upcoming conference on Practical Solutions in CSV and SDLC for GXP & MedDev (London,...
Why digitised design control is essential for the sustainability of your DHF
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Posts about: Requirements and Traceability
The difference between data integrity & data quality in medical technology companies – and why you must care
Data is the lifeblood of any Life Sciences company - and trust is the heart. For those of us that manage data, we cannot and will not allow drugs or medtech devices to...
Agile and design controls: From story to specifications
Doing Agile in a GXP or medical devices environment requires you to serve two masters: you need to practice the Agile disciplines on one side, and embrace regulatory...
Requirement specifications
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...
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...
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...
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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