IT Project Management: A Validation Challenge
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.
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. Topics covered in the publication describe bad and good practices observed during many years of our experience in the industry.
Are you ready for the MDR? This is how new EU regulations may impact medical device producers
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.
Who, when and how should prepare for the amendment of Annex 1?
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.
Overcoming the digital delay: Why organisations must prioritise digital transformation
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.
Cornerstone OnDemand: a strategic leader in the learning system market
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.
