Ensuring Data Integrity with the Allotrope Framework

Data integrity is a hot topic in 2018 and for good reason.  Pharmaceutical and biotech companies produce an enormous amount of experimental R&D data. The sheer volume and complexity of the data makes managing this critical asset challenging. Leading companies are thus investing heavily in initiatives aimed at more effectively managing experimental data across its full lifecycle in hopes of driving the innovation necessary to stay competitive and ensure data integrity.

The FDA has been stepping up its efforts to evaluate data integrity issues within the pharmaceutical industry due to a growing trend of observed data integrity violations. While the Quality Control laboratory has historically been the main focus of inspections, R&D laboratories, clinical research efforts and batch records in production are now also starting to come under regulatory data integrity scrutiny.

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