Validating Open Source eClinical Systems

Validating software you use in clinical research is a requirement of most regulatory authorities, such as the FDA under 21 CFR Part 11. It’s also generally considered a good practice that ensures a system adequately meets your needs. However, validating software can be a confusing topic to many. Validation WP

In her white paper, “Validating Open Source eClinical Systems” validation expert, Laura Keita, articulates the validation process and responsibilities, and simplifies the principles of validation by focusing on the core mantra: “plan it, do it, prove it.” The paper also looks at validation strategies for open source eclinical software, and how the FDA has acknowledged the impact the open source model has on improved software quality—all part of the spirit of validation.

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