By Christian Wolbeling
Increase in data integrity violations
In the last years, the FDA has seen an increase in data integrity violations. The number of Data Integrity warning letters has increased from 4 in 2011 to 55 in 2017. Why? Andrew Hopkins, MHRA, explained to me that they “are now watching closely what the industry is supposed to do”. Interestingly, the requirements have not changed. For example, record retention and review do not differ by data format: As Paula Katz, FDA, stated, “paper-based and electronic data record keeping systems are subject to the same requirements”.
Reasons for data integrity violations
US regulators, for example, are enforcing the availability of drugs on the market due to current drug shortages and lack of quality. Lawrence Yu, FDA, says that “the fundamental problem we identify is the inability of the market to observe and reward quality. This lack of reward for quality can reinforce price competition and encourage manufacturers to keep costs down by minimizing quality investments.” He requests the industry to invest and use state-of-the-art technologies like manufacturing IT systems to improve the quality and to operate a “Process Performance & Product Quality Monitoring System”, as stated in ICH Q10.
Read how Manufacturing Execution Systems (MES) can prevent these issues with their incorporated ALCOA+-based functionalities.