Data Integrity Risk Assessment

Health Canada, FDA and other Regulatory Agencies have an expectation that companies understand the capability of their systems that generate and store data/records including any data integrity risks associated with such systems.

It is important for companies to execute comprehensive Data Integrity Risk Assessments for systems that generate and store both paper (manual)-based systems as well as computer-based and hybrid systems.

The purpose is to identify risks to patient safety, product quality and Data Integrity as well as to identify the actions to mitigate such risks.

GMP Consultants has performed Data Integrity Risk Assessment for large Pharma companies. The procedures and assessment have been inspected by Regulatory Agencies and found to be complete, comprehensive and complaint to expectations.

We determine the risk associated with generated data/records in terms of the requirement that the data is complete, accurate, consistent, trustworthy and reliable throughout the lifecycle of the record (i.e. from data creation, processing, review/reporting/use, retention/retrieval and destruction).