Financial and organizational advantages also speak for the use of cloud services in the pharmaceutical environment. However, potential risks and regulatory restrictions should be known. Nine experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Question 1: What is the meaning of IaaS / PaaS / SaaS / XaaS?
GMP deficiencies are often identified during FDA inspections. Responding to an FDA deficiency report is important, otherwise a Warning Letter may be issued. But how should one respond?
Data integrity is still one of the major topics in FDA inspections. Missing controls to ensure the integrity of electronic data as well as inadequate access controls were some of the reasons why a Warning Letter to American company Vi-Jon was issued.
At the end of July 2022, the GAMP organization has published the 2nd Edition of GAMP® 5. What are the main changes and developments compared to the previous version, which has been available since 2008?
The FDA would like to use so-called Remote Regulatory Assessments (RRAs) not only during the COVID-19 pandemic, but also beyond it for the asessments of establishments and applications and has published a Draft Guidance for Industry on this.
In June 2022, the U.S. FDA issued a Warning Letter tto the Dutch company "Fagron Group B.V." after having inspected their US American site "Fagron Inc." in November 2021.
On 8 April 2022, the FDA published a new draft guidance "Cybersecurity in Medical Devices..." to replace the previous guidance from 2014. Why did the FDA publish this draft?
Last year, the WHO replaced the previous Guidance on good data and record management practices with a new Guideline on data integrity. What has changed?
