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21 CFR Part 11 is a crucial component of regulatory compliance in clinical trials and, more broadly, any industry subject to the regulations of the U.S. The regulation was established in 1997 to address the FDA’s concerns regarding the use of electronic records and signatures, ensuring their integrity, accuracy, and confidentiality.
Integration with LaboratoryInformationManagementSystems (LIMS) Integrating Cloudbyz EDC with LIMS allows for efficient management of laboratory data, including test results, sample tracking, and workflow management.
The clinical research industry is in the midst of a digital revolution, with Clinical Trial Management Software (CTMS) at the forefront of this transformation. The Early Days: Legacy CTMS Systems In the early days of clinical research, managing trials was a manual, paper-based process.
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