Validation by design transforms the way the validation is traditionally performed. Applying Validation by Design will require to adopt a new way of thinking and working as the system requirements should be verified during it development, configuration and implementation.
Periodic Review is a key program of quality system that helps ensure compliance. It is used to verify that validated systems remain compliant with the appropriate quality and safety regulations as well as ensuring that the validated systems remain fit for their intended use.
A systematic, independent and documented process for obtaining and objectively evaluating evidence to determine the extent to which audit criteria are met. The goal is to confirm that the quality system of your supplier is in place and effective to guarantee the quality of services and products.
Mastering and controlling GxP data is essential to ensure that data obtained through GxP activities are complete, consistent and precise and thus guarantee decision-making by pharmaceutical industries and laboratories; and the competent authorities.
Process Digitalization is a method, a program by which some digital technologies are being used in the processes and managing data digitally, in order to convert processes into processes more efficient, more productive and more profitable.
Creating intelligent processes, procedures, products, services, business models and customer access is key characteristic of Digital Transformation. That mean you have to digitize and integrate process vertically and horizontally across the entire organization.