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Facing ever-tighter regulation of everything from production processes to customer information management and product labelling means Pharma companies are having to find more practical, effective ways to integrate governance policies, address litigation risk and manage compliance on an increasingly global scale. To meet these challenges cost-effectively you require a culture of synergies – combining economical industry processes with technology that addresses current and emerging requirements.
In order to thrive in today’s world of connectivity, convergence of services, and globalisation, heavily regulated companies must partner with their service providers to ensure both high quality service and regulatory compliance. Service providers must support clients from an environment that satisfies the regulatory needs, including that the service providers’ software tools are validated to the set industry standards required.
To this end, uniquely, BT has established a dedicated Regulatory Compliance Practice with the Pharmaceutical expertise to support our customers to meet the requirements set by industry regulations such as ICH GxP and US FDA 21CFR Part 11.
Our dedicated compliance practice has the technology, the infrastructure and the regulatory knowledge to help you throughout the validation cycle, from risk assessment to periodic review, and for applications to help you manage IT infrastructure and global business systems including R&D.
As we ourselves operate in a highly regulated environment we understand the rigours of achieving compliance. Our compliance practice can help you to rationalise your processes and streamline the interface between your organisation, third parties and regulating bodies.
To find out more about how we can ensure regulatory compliance visit BT Assure.
