Whitepaper: Enabling data integrity during drug manufacturing
High data quality and integrity is critical to ensure successful manufacturing of a drug. This whitepaper discusses how utilisation of software systems such as SampleManager LIMS enables and promotes compliance with regulations for the manufacturing of a drug.
Promoting an environment to ensure high quality data
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 ensure 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 regulatory guidance is being followed and that their data is of the highest integrity. High data quality and integrity is critical to ensure successful manufacturing of a drug.