Tuesday, 05 July 2022

Ankura launches pharma data integrity solution

08 March 2022 | News

Data integrity early-warning system assists pharma clients in proactively identifying and managing data integrity challenges in line with regulatory guidelines

Image credit: Shutterstock

Image credit: Shutterstock

Advisory firm Ankura Consulting has announced the expansion of its pharmaceutical and biopharma regulatory compliance offering with the addition of a Pharmaceutical Data Integrity solution within the data and technology practice, bolstering its comprehensive client advisory capabilities.

 

The offering includes an Early Warning System (EWS), an automated platform to help identify data integrity anomalies in real-time and assist companies in performing forensic data integrity investigations and remediation for any regulatory action such as form 483, warning letter, an import alert. 

 

The EWS solution also solves the challenge of integrating multiple quality systems (such as CDS, NON CDS and LIMS) into one platform, enabling the quality control department to take advantage of the integrated monitoring capabilities and providing alerts for any non-compliant activities. It also provides the flexibility to customise and deploy the solution to an on-premises environment and customise the workflows and analytics models for each organisation.

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