September 1, 2020
Automated Testing

Lack of Assessment of Automated Test Execution Tools

Automated test execution tools can be used to improve efficiency and effectiveness. Like other software, test automation software may be standard, configurable, or custom, and should be specified and verified appropriately based on an assessment of risk; however, auditors frequently note that GxP software developers do not assess these tools […]
May 19, 2020

Validation and Qualification of eClinical Systems (2) – Contracts/Agreements

After the selection of a vendor, appropriate contracts should be put in place prior to the commencement of work. Contracts should clearly detail the delegated tasks, duties and functions between the parties, and the required standards of service.
May 13, 2020

Validation and Qualification of eClinical Systems (1)

Based on recent inspection findings, the GCP Inspectors Working Group  (IWG) and the Committee for Medicinal Products For Human Use (CHMP) recognize the need to emphasize requirements for sponsors/vendors providing computerised systems or services as well as for the qualification and validation of computerised systems used to manage clinical trial […]