Problem: Does the design validation of your CTMS incorporate the system's capability to create and verify the confidentiality, integrity and authenticity of electronic signatures as well as records imported from external sources such as, third-party Electronic Data Collection (EDC) systems, with the appropriate safeguards in place to assure data and document retention per ICH record retention guidelines (FDA, 2018) (Johannesson, 2023) (Thakkar, 2024)? Need Professional Help?