Posted by Mumbai: Ankura Consulting has expanded its pharmaceutical and biopharma regulatory compliance offering. Ankura has added a Pharmaceutical Data Integrity solution within the Data and Technology practice, bolstering its comprehensive client advisory capabilities.
With this new solution, the global expert services and advisory firm has enhanced its team of experts to support pharmaceutical clients’ compliance with the data integrity guidelines of multiple regulators through advanced digital technology.
The offering includes an Early Warning System (EWS), which is an automated platform to help identify data integrity anomalies in real-time. It assists 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 pharmaceutical 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,” said Amit Jaju, Senior MD – Ankura’s Data and Technology practice.
“EWS enables this transition and allows early identification of any anomaly, falsification activities, and DI deviations from a regulatory compliance perspective,” added Jaju.
The EWS solution also integrates multiple quality systems (such as CDS, NON-CDS and LIMS) into one platform, enabling the quality control department with integrated monitoring capabilities and providing alerts for any non-compliant activities.
It also provides the flexibility to customize and deploy the solution to an on-premises environment and customize the workflows and analytics models to each organisation.
“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,” said Paul Walker, Senior MD – Ankura’s Data and Technology practice.
“Many regulators now recommend appointing a qualified consultant for the investigation and remediation activity,” added Walker.
Further, Walker said that Ankura’s Data Integrity investigation and remediation offering is a pivotal tool to support clients in performing comprehensive data integrity analysis using big data and an advanced analytical approach on 100% of the data as compared to the sample manual review. .