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: Computer Systems Validation (CSV)
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...
How paperless validation assists pharma success
Why should I implement paperless validation For many of the medtech and pharmaceutical companies I consult, there’s a common clash of the validation systems “worlds”...
Heading toward hands-free validation
Over the course of working with dozens of innovative, exceptional companies, I'm always struck by their commonalities of purpose and validation process. While they all...
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...
Stuttgart Summit: Highlights & takeaways on how to validate software development tools for GXP and MedDev
Last week a select group of 15 health sector professionals representing businesses from startups to large pharmaceutical companies gathered in Stuttgart, Germany for...
Advice for selecting traceability matrices
What qualities are crucial when selecting traceability matrices? Without the right tools in place, traceability matrices can easily bring a project to the brink of...
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...
Process mapping with SIPOC in Jira
Implementing a new computer system Whenever you're implementing a new computer system or having an old one updated, your goal is finding how to best support your...
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...
Planning for validation
Planning your project and planning your validation are very closely intertwined and, when your project process is mature, these will converge to become one thing. Our...
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...
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