Enabling Data Integrity from Drug Discovery through Manufacturing
White Paper Sep 19, 2018
When discussing the success of a drug therapy, a common topic amongst biopharmaceutical companies is data quality and data integrity; what the challenges are and what the key elements are to ensuring that the latest discovery is patentable, does not result in re-conducting critical research or development studies, is accepted by the regulators, or does not result in a recall of a batch of product.
A common challenge expressed amongst the industry is how to implement processes that promote and ensure that regulatory guidance’s are being followed and that their data is of the highest integrity.
High data quality and integrity is critical to ensure patient safety and drug efficacy from research and development through to manufacturing.