Is Cloud Computing Open or Closed System according to 21 CFR Part 11?
The trend in the pharmaceutical industry is also moving towards cloud computing. Financial but also…
The trend in the pharmaceutical industry is also moving towards cloud computing. Financial but also…
The EDQM has announced the addition of a new FAQ to its existing series, addressing the system suit…
Latest update on 08.01.2025 The nitrosamine Q&A document 'Questions and answers for marketi…
Subscribe here to get regular updates Get Regular updates here
There is relatively little information on FDA requirements for equipment qualification. You can fin…
FDA warning letters, the FDA sometimes advises the employment of a consultant in order to remedy t…
The ICH Secretariat announced the publication of the updated Q9(R1) Annex 1- Q8/Q9/Q10 Questions &a…
The topic of "risk" appears 16 times in FDA's Process Validation Guidance. Annex 15 t…
The European Shortages Monitoring Platform (ESMP) has gone live with a core set of functionalities.…
The trend in the pharmaceutical industry is also moving towards cloud computing. Financial but also…