Data Integrity Services
Resolving Data Integrity Challenges and Securing Compliance for Pharmaceutical Companies
Data integrity audits conducted by regulatory agencies such as the United States Food and Drug Administration (US FDA), Indian Food and Drug Administration (FDA), the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) and other regulatory agencies pose immense challenges for pharmaceutical companies. A globally dispersed supply chain, large and complex data sets, insufficient systems control, a lack of training or appropriate manpower – all of these factors can decrease the company’s ability to achieve data integrity compliance and increase the chances of enforcement actions by regulators such as costly fines and penalties.
As the rate of data integrity audits accelerates, pharmaceutical companies need to ensure that data (both electronic and paper-based) is reliable, accurate and managed in accordance with the Current Good Manufacturing Practice (CGMP) regulations. And, to accomplish good data integrity practices, pharma companies need to take necessary measures to identify and implement the correct processes and technology to remedy errors and attain compliance.