In the draft, MHRA calls for companies to adopt a working environment and organizational culture that ensure the completeness, consistency and accuracy of data, regardless of whether it is kept on paper or electronically. MHRA is advocating for a risk-based approach. As such, firms should commit more time and resources to ensuring the validity of data if an integrity failure could detrimentally affect patients or the environment.
“Organizations are not expected to implement a forensic approach to data checking on a routine basis, but instead design and operate a fully documented system that provides an acceptable state of control based on the data integrity risk with supporting rationale,” MHRA wrote. This entails carrying out routine data reviews to assess the integrity of individual datasets, while also performing periodic audits to ensure the effectiveness of existing control measures.
The draft guidance applies to both paper and electronic data.