Data integrity,importance and compliance

Amit Shandilya, Sr GM, Zydus Life, started his presentation by sharing the history of data integrity with the audience. Citing an example, he said that regulators uncovered list of issues including fake drug quality data and banned 30 products from the US market; and in 2009, the United States Food and Drug Administration (USFDA) started the post-inspection responses programme. He further informed that in the last three years, the USFDA has issued over 30 warning letters and Form 483 inspectional observations related to electronic records.

He then talked about the ALCOA principle in data integrity. ALCOA stands for Attributable (where sign and date are required), Legible (data must be readable), Contemporaneous (data must be recorded concurrently), Original (data must be preserved in its unaltered state), Accurate (data must be actual and free from errors). In addition, he said, “Data must be recorded in consistent manner on authorised media, and must be available throughout lifecycle.”

Suggesting to bring in the tool of automation for maintaining data integrity, Shandilya also said, “We cannot change the human condition, but we can change the conditions under which humans work.”

He further put forward another way to sustain data integrity – Quality Excellence by Sustainable Transformation (QUEST). Under QUEST, he recommended QUEST circles across site, daily dialogue, idea generation and implementation, GEMBA walk by leadership team, focus on data integrity training (bottom to senior management), displays for correct practices of quality culture, town hall with CW to senior management, display of senior management’s contact number (openness for DI, GMP and GDP discussion), and R&R for the best-quality idea implementation. He also said that one can trust, harmonise, collaborate and communicate for attaining better data integrity.

“Data integrity breaches in- volve some unintentional mistakes. It’s all about behaviour, processes, culture, awareness and education,” he notified.