Wednesday, June 3, 2015

Concerns around data integrity among pharmaceutical companies

One third of pharmaceutical companies have not conducted reviews to assess potential gaps in data integrity, according to an EY survey, ‘Analysing the state of Data Integrity Compliance in the Indian Pharmaceutical Industry’. Data Integrity Reviews are conducted to evaluate if data records are accurate, complete, attributable, legible and maintained within their original context in electronic or paper form. Over 30% of the respondents stated that they have received inspectional observations by regulators. This was despite signing off their understanding and compliance with Good Manufacturing Practices (GMP) norms.

“Maintaining data integrity is crucial for the pharmaceutical sector. Today, companies with existing or anticipated concerns around data integrity should initiate regular proactive data integrity assessments. This will be beneficial even for companies that enjoy a good reputation in the market. These periodic assessments provide assurance to all stakeholders involved - customers, investors, regulators as well as reaffirm the management’s commitment toward highest standards of quality.” adds Rajiv Joshi, Partner, Fraud Investigation & Dispute Services, EY.