Author: admin

Agile – Theory vs. Practice

My manifesto:

1. Ignore the jumbled mess of process frameworks like SAFe and highly-paid consultants’ jargon

2. Read all you can on the tradeoffs of agile processes, principles, roles, ceremonies, tools, etc. (*most companies claiming agility cannot and / or will not cede decision making power to their development teams)

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zwerit.com
Curves comparison and plotting algorithm with an emphasis on In-vitro drug dissolution testing

This paper presents a Python algorithm for evaluation of difference factor f1 and similarity factor f2 as a criterion for assessment of similarity between two in-vitro dissolution profiles as proposed in the EMEA and SUPAC-IR Guidance. It accelerates and facilitates the pharmaceutical developers everyday work by providing quick calculations and charts.

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QA Medical Industry: Registering medical device standalone software on the EU market – part 2

QA Medical Industry: Registering medical device standalone software on the EU market   Part Two In the preceding part of the article, we have tried to provide a summary of the first steps that should be taken into the certification process for a Software as a Medical Device. The successive part of the path can be […]

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QA Medical Industry: Registering medical device standalone software on the EU market

QA Medical Industry: Registering medical device standalone software on the EU market   Part One   In the health-care domain, over the years, software has become a pervasive technology, no longer confined to controlling traditional medical devices (e.g., radiology equipment). Medical purpose software has been assuming increasing responsibilities by redefining classic health-care services or offering […]

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