The requirements brought in by the Medical Device Regulation have posed a serious challenge for many companies operating in the medical device industry. Adapting to
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
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
The use of quality assurance outsourcing solutions seems to be revolutionary to some, but is there really anything to be afraid of? Outsourcing is simply
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 of its products.
This article presents observations on the performance of work related to the commissioning of a new area at the initial stage of investment.
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.
Validation is going through a paradigm shift. The new way of doing things is called Computer Software Assurance (CSA).
One of the increasingly popular forms of cloud computing are so-called SaaS services, or Software as a Service.
The pharmaceutical industry is characterised by numerous requirements governing its functioning.