IT Project Management: A Validation Challenge

Changing Project Management Methodology From Traditional to Agile PM

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.

Who, when and how should prepare for the amendment of Annex 1?

Team of Scientists in Sterile Protective Clothing Work on a Modern Industrial 3D Printing Machinery. Pharmaceutical, Biotechnological and Semiconductor Creating / Manufacturing Process.

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.