There are limitations to how much property can be protected after a disaster. In the case of clinical research sites, paper documents can burn, or they can be damaged or destroyed by smoke and water. An important consideration for sites is to develop a disaster preparedness strategy with a focus on transitioning to paperless documentation by moving critical study documents to a digital format.
While electronic document management is becoming more mainstream, it’s still considered uncharted territory for some research sites. The transition is often approached with trepidation, fear, and questions. Complion has found sponsor pushback to be a common concern. To that end, Complion offers a few tips to ease the apprehension.
The characteristic increases in efficiency as a result of transitioning to a streamlined paperless operation are of little value if the transformed organization fails to be 21 CFR Part 11 compliant. It’s critical every step to paperless transformation is guided by professionals who are skilled in the requirements for compliance.