Concerns over data integrity still prevail at Indian pharmaceutical companies as a third of them have not conducted reviews to assess the potential gaps, says an EY survey titled, Analysing the state of data integrity compliance in the Indian pharmaceutical industry. While more than 30% of respondents had received inspectional observations by global regulators, 57% admitted seeing manufacturing personnel under immense work pressure, impacting overall efficiency.
The survey also pointed out that 28% of respondents indicated that their organisations did not have a fraud reporting mechanism in place. In such a guarded industry, lack of whistle-blowing policies means individuals who genuinely want to help their organizations by flagging any unethical acts or wrongdoings may be forced to report such issues externally, the report said.
Data integrity reviews are conducted to evaluate if data records are accurate, complete, attributable and legible.