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 the new legal reality requires a significant amount of time and effort. We have prepared a short guide for the transition process based on the
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. In addition to the obvious benefits stemming from the digitization and automation of processes, the progressive computerization of the pharmaceutical industry also has a second, slightly less-beneficial side.
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 a new system requires special prudence and supervision.
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 separating some of the functions a company conducts independently from the organizational structure and contracting them to other entities. This form of cooperation has been
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. Topics covered in the publication describe bad and good practices observed during many years of our experience in the industry.
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. European Union expects full adherence across all its member states. Find out what this means for your company.
The pharmaceutical industry is characterised by numerous requirements governing its functioning. In my professional history, I have yet to meet an employee of this industry, who couldn’t wait to see an amendment to the Good Manufacturing Practice (GMP) requirements.
By Geoffroy de Lestrange, International Product Marketing and Communication Director at Cornerstone OnDemand.
This year, many saw digital transformation efforts really take off in their organisations, across all departments.
Validation is going through a paradigm shift. The new way of doing things is called Computer Software Assurance (CSA). It’s founded on critical thinking and intended as an improvement on the long-standing Computer System Validation (CSV) standard.
Employees’ skills are crucial for company success. They can drive the business towards higher profits if they’re well-aligned with the organization’s strategy.
One of the increasingly popular forms of cloud computing are so-called SaaS services, or Software as a Service.
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 the new legal reality requires a significant amount of time and effort. We have prepared a short guide for the transition process based on the
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. In addition to the obvious benefits stemming from the digitization and automation of processes, the progressive computerization of the pharmaceutical industry also has a second, slightly less-beneficial side.
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 a new system requires special prudence and supervision.
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 separating some of the functions a company conducts independently from the organizational structure and contracting them to other entities. This form of cooperation has been
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. Topics covered in the publication describe bad and good practices observed during many years of our experience in the industry.
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. European Union expects full adherence across all its member states. Find out what this means for your company.
The pharmaceutical industry is characterised by numerous requirements governing its functioning. In my professional history, I have yet to meet an employee of this industry, who couldn’t wait to see an amendment to the Good Manufacturing Practice (GMP) requirements.
By Geoffroy de Lestrange, International Product Marketing and Communication Director at Cornerstone OnDemand.
This year, many saw digital transformation efforts really take off in their organisations, across all departments.
Validation is going through a paradigm shift. The new way of doing things is called Computer Software Assurance (CSA). It’s founded on critical thinking and intended as an improvement on the long-standing Computer System Validation (CSV) standard.
Employees’ skills are crucial for company success. They can drive the business towards higher profits if they’re well-aligned with the organization’s strategy.
One of the increasingly popular forms of cloud computing are so-called SaaS services, or Software as a Service.
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