FDA released a draft guidance: Computer Software Assurance for Production and Quality System Software. What changes could it bring?
Gamp 5 Version 2 released in July 2022 brings new updates for computerized systems in the Life Science industry.
Are you ready to implement the EU ISO IDMP standards for medicinal products? Discover with us how to safely move to the new standards
The Life Science industry revolution goes along with the development of data interoperability systems that allow shared data within the entire.
Cleaning Validation for Biotech products: our expert Marco Paolillo addresses the main challenges in the process.
The Ministry of Health of Israel has just been included in the Medical Device Single Audit Program (MDSAP), what are the changes?
Cleaning Validation in the Pharmaceutical Industry: our expert Marco Paolillo addresses the 5Wsv to avoid contamination and cross-contamination.
After Covid-19 Pandemic, with FDA almost set to start remote auditing, is your company inspection ready?
How does the Annex I shape the Environmental Monitoring strategy in your sterile facility?
Effective June 30, 2022, the registration procedure for Food Supplement notification in Italy has changed.
