March 7, 2022
Data Integrity Early-Warning System Assists Pharmaceutical Clients In Proactively Identifying and Managing Data Integrity Challenges in line with Regulatory Guidelines
Ankura Consulting, LLC (“Ankura”), a leading global expert services and advisory firm, today 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.
With this solution, Ankura 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 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 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. 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 in Ankura’s Data & Technology practice.
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 customize and deploy the solution to an on-premises environment and customize the workflows and analytics models to each organization.
“The cost of being non-compliant to data integrity can be a high-priced affair, and in many cases becomes difficult for companies and organizations 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 in Ankura’s Data & Technology practice. In light of this, 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 advanced analytical approach on 100% of the data as compared to the sample manual review approach followed in the industry.”