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How to do business under MDR? A 12-step guide to preparing your company for the new regulations
The requirements brought in by the Medical Device Regulation have posed a serious challenge for
Data integrity – order and security
Modern IT solutions and industry automation are changing the world, and in many areas are contributing to the dynamic development of various sectors, including the pharmaceutical industry.
How to mitigate risk in validating a cloud solution?
Companies are eager to implement cloud solutions, so they can cut costs and streamline their business efficiency.
Quality outsourcing – is it possible?
The use of quality assurance outsourcing solutions seems to be revolutionary to some, but is there really anything to be afraid of?
IT Project Management: A Validation Challenge
Computer system validation is a procedure performed in every pharmaceutical or medical device company that uses IT systems at the stage of production, logistics or distribution of its products.
The first stage of implementing a new manufacturing area — good and bad practices
This article presents observations on the performance of work related to the commissioning of a new area at the initial stage of investment.
Are you ready for the MDR? This is how new EU regulations may impact medical device producers
Medtech companies are facing major compliance challenges.
Who, when and how should prepare for the amendment of Annex 1?
The pharmaceutical industry is characterised by numerous requirements governing its functioning.
Computer System Validation – SaaS solutions
One of the increasingly popular forms of cloud computing are so-called SaaS services, or Software as a Service.
From CSV to CSA – what should you know about the new validation paradigm?
Validation is going through a paradigm shift. The new way of doing things is called Computer Software Assurance (CSA).
Recommended
01
Computer System Validation – SaaS solutions
One of the increasingly popular forms of cloud computing are so-called SaaS services, or Software as a Service.
02
From CSV to CSA – what should you know about the new validation paradigm?
Validation is going through a paradigm shift. The new way of doing things is called Computer Software Assurance (CSA).
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Computer System Validation
