TECH OUTLOOK 8DECEMBER - 2021IN MY OPINIONWhat the New EMA Draft "Guideline on Computerized Systems and Electronic Data" Means to Your SystemsBy Cathlin Shapiro, Director, Technology Quality Assurance, ParexelAs the EMA released a new draft guideline in June 2021 for comments from the industry, those of us who manage clinical systems analyzed the 47-page document to see how the EMA sees the future of compliance of systems and data. This encompassing guideline presents a clear roadmap on how companies should be controlling their approaches to compliance of regulated systems and is a tool that can be used for updating existing procedures and planning for newer technologies such as wearables/sensors, artificial intelligence and real-world data/evidence. The new guideline is a welcome addition to the GCP world, as other previous regulatory guidance in computerized systems or data integrity has been limited to GMP scope nor included specific examples of the types of systems used in clinical research. This article highlights some of the key points for managers to be aware of for when this draft guidance is finalized in the future, as comments are still open for industry review until December 2021.The EMA draft guideline 226170/2021 contains a broad scope of topic areas related to computerized systems and the control of electronic data in clinical trials, including the principles of data integrity, computer system validation, audit trail review, devices used in ePRO systems, migration of data, and notably a large section on information security aspects, one area that is often neglected in regulatory guidance from practical application in daily operations. Is your company meeting the expectations in these areas?Data Integrity and ALCOA++Many of us are familiar with the tenets of data integrity and the ALCOA concepts, but the EMA has included another "+" to the definition, additionally calling out the need for data to be traceable. To meet this requirement companies must scrutinize if they are able to construct and have the documentation readily available to display the traceability of data from all sources and into which systems for ultimate clinical analysis. This definition of traceable may be different from the traceability matrix created for computer system validation activities, which maps requirements to design to testing, as data integrity traceability may be captured in architecture or data flow diagrams or other means to capture disparate data flows and usages. In addition, any change to the data would need to be captured to ensure traceability. The EMA stresses again how important data integrity is to the output of the clinical trials, as Cathlin Shapiro
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