Driving Consistency in Validation Management

ABSTRACT

FDA also explained that system designs and controls should allow for detecting errors, omissions, and unusual results-outcomes that cannot be easily identified with paper-based processes. Because the guidance requirements for record retention and review don't differ between paper or electronic, this update supports the shift to a digital model. Using paper to check and mark things off is a normal practice in life sciences, even if it is not a very good process for error detection, data collection, or metrics, says Bryony Borneo, quality assurance director at global contract research organization (CRO) Emmes. Building a solid data foundation and gaining more experience with remote ways of working are driving positive change and making it easier for quality teams to remain compliant with regulations. According to Sanjeev Kumar, senior director, data integrity and technology at Vertex Pharmaceuticals, there is greater awareness of data standardization to identify developing trends and insights from information.