Data Integrity in the Life Sciences market is crucial to the production and export of drugs and medical devices around the globe. Incomplete or inaccurate data can result in the FDA or other Governing Bodies classifying a facility as being not in control of processes and/or the end product not being fit for consumption.
It is critical the data collected comes from a valid and trustworthy source, and companies can prove its accuracy. Through auditing any data irregularities can result in products being seized or recalled, penalties are imposed, and can potentially lead to a facility loosing its license to manufacture, thus the need for data integrity. Incomplete records and faulty documentation due to human error or worse are still a prominent issue for Life Science companies all over the world.
Zenith Technologies specialise in the specification, coding, implementation, and commission and qualification of computerised systems in regulated pharmaceutical environments. We facilitate pharmaceutical clients with the development of their user-requirements, project-execution, quality and validation strategies, with the development of their operational and maintenance processes, and planning upgrade/replacement strategies.
Central to our lifecycle activities is an emphasis on risk-based validation, compliant operational controls, assurances on data-integrity and audit trails, and robust data and record transfers between different business systems and manufacturing systems.
We can assess existing and new systems for accurate compliance to international good manufacturing practices and develop mitigation strategies to address any gaps. Our mitigation strategies are technologically focused rather than an over reliance on procedural controls.