The latest GAMP Good Practice Guide on Data Integrity by Design recommends that data integrity be designed into a process using technical controls that can be applied consistently rather than a patchwork of procedural controls that are inconsistently applied. In assessment and remediation activities, many laboratories focus on computerized systems but often fail to consider data vulnerabilities inherent with paper-based processes that are manually documented such as sample preparation.
“Voice data input is a great technology for simultaneous working and data entry.”
Bob McDowall
Data Integrity Consultant and Director of R&D McDowall Limited