The requirements brought in by the Medical Device Regulation have posed a serious challenge for many companies operating in the medical device industry.
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Modern IT solutions and industry automation are changing the world, and in many areas are contributing to the dynamic development of various sectors.
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Companies are eager to implement cloud solutions, so they can cut costs and streamline their business efficiency. However, within pharmaceutical and life science industries, implementing cloud solutions poses unique challenges.
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The use of quality assurance outsourcing solutions seems to be revolutionary to some, but is there really anything to be afraid of?
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Computer systems validation is a procedure performed in every pharmaceutical or medical device company that uses IT systems at the stage of production, logistics or distribution.
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This article presents observations on the performance of work related to the commissioning of a new area at the initial stage of investment.
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Medtech companies are facing major compliance challenges. As of May 26, 2021 new Medical Devices Regulation goes into effect and previous directives cease to apply.
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Validation is going through a paradigm shift. The new way of doing things is called Computer Software Assurance (CSA).
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One of the increasingly popular forms of cloud computing are so-called SaaS services, or Software as a Service.
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The pharmaceutical industry is characterised by numerous requirements governing its functioning.
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