Quality Oversight of Cloud-based Systems
Draft Title: Quality Oversight of Cloud Based Systems
Date: 12th July 2021
Who to Contact: projectenquiries@pistoiaalliance.org
Problem Statement
The European Medicines Agency has issued a notice (7th April 2020) to sponsors of a clinical study that could be interpreted to mean that the sponsor must have full visibility on the specificity and testing documentation for cloud-based applications used in pharmacovigilance and GxP processes:
Some Pistoia Alliance pharma members involved in IT Quality Assurance and Compliance anticipate that vendors of cloud-based may not be prepared to provide such documentation and as such this provides a challenge to the sponsors of clinical studies.
Next Steps
The Pistoia Alliance is organizing roundtable discussions to permit the pharma member companies to discuss this issue and share their interpretation and proposed solutions as well as experiences requesting such documentation from specific vendors.