The International Society of Pharmaceutical Engineering publishes the Good Automated Practices Guides including GAMP from 2008 which coverscomputer system validation in general and a number of more recent guides on topics ranging from mobile apps to IT infrastructure control. The current list of available guides is: GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized...Read More

In July 2015 an amendment was issued to IEC 62304. While this amendment was focused on additions for legacy software and clarifications to the use of risk in safety classification, keep in mind that a number of other smaller changes and additions were made. Some of the more significant ones include: Reduction in the exemptions...Read More

In July 2015 an amendment was issued to IEC 62304. While this amendment was focused on additions for Legacy software and clarifications to the use of risk in safety classification keep in mind that a number of other smaller changes and additions were made. Some of the more significant ones include: 1. Reduction in the...Read More