Computerized systems can be a boon to the Sales and Marketing group of an organization that falls within FDA regulatory authority.
By automating, tracking, and reporting on thousands of sample product transactions, such systems can provide a powerful mechanism for compliance to the requirements of the Prescription Drug Marketing Act (PDMA), while accomplishing this with a manageable level of effort. However, these systems can get bogged down during implementation due to the need for excessive validation testing and documentation. This, in turn, can lead to lengthy and sometimes fatal delays for roll-out to production.
How can such systems be validated in an efficient manner and with a level of documentation commensurate with actual regulatory risks? The key is to plan for validation at the beginning of the project with a fundamental focus on the development of good user requirements. Such requirements can be utilized to determine the extent of validation and to target the testing effort on the critical, regulated functionalities of the PDMA system. The result is a validation effort that can be optimized from both a cost and time perspective.
By automating, tracking, and reporting on thousands of sample product transactions, such systems can provide a powerful mechanism for compliance to the requirements of the Prescription Drug Marketing Act (PDMA), while accomplishing this with a manageable level of effort. However, these systems can get bogged down during implementation due to the need for excessive validation testing and documentation. This, in turn, can lead to lengthy and sometimes fatal delays for roll-out to production.
How can such systems be validated in an efficient manner and with a level of documentation commensurate with actual regulatory risks? The key is to plan for validation at the beginning of the project with a fundamental focus on the development of good user requirements. Such requirements can be utilized to determine the extent of validation and to target the testing effort on the critical, regulated functionalities of the PDMA system. The result is a validation effort that can be optimized from both a cost and time perspective.
