Express Pharma

Ankura launches pharma data integrity solution

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

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Ankura Consulting today announced the expansion of its pharma and biopharma regulatory compliance offering with the addition of a pharmaceutical data integrity solution within the data and technology practice, bolstering its comprehensive client advisery capabilities, a company statement said.

It also said that with this solution, Ankura has enhanced its team of experts to support pharma clients’ compliance with the data integrity guidelines of multiple regulators through advanced digital technology. The offering includes 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 and import alert.

“In the endeavour to embrace industry 4.0, the pharma industry should explore giving up manual and fragmented means of managing compliance procedures and implement digital technologies in the quality control laboratories to proactively identify any Data Integrity (DI) gaps in real-time. EWS enables this transition and allows for early identification of any anomaly, falsification activities and DI deviations from a regulatory compliance perspective,” said Amit Jaju, Senior Managing Director, Data and Technology practice, Ankura, in the statement.

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 to each organisation, added the statement.

“The cost of being non-compliant to data integrity can be a high-priced affair, and in many cases becomes difficult for companies and organisations to gain back the trust of regulators once breached. Many regulators now recommend appointing a qualified consultant for the investigation and remediation activity,” said Paul Walker, Senior Managing Director, Data and Technology practice, Ankura, in the statement.

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