Source data, the original entry for data in research or manufacturing, is expected to contain certain elements of Quality in the Pharma industry. These elements are often expressed with the acronym ALCOA (i.e., Attributable, Legible, Contemporaneous, Original, and Accurate).
I have worked extensively in evaluating electronic data issues, especially in how they relate to clinical research, so I am very interested to see how how EMEA’s position varies from FDA’s. I will be reviewing this paper thoroughly and time permitting, I may include a summary here. ~TJK