Issue 7 - Ensuring Accuracy and Integrity in Bioanalytical Methods and Laboratory-Developed Tests
Octet?- Affinity, Binding Kinetics and Concentration
Label-Free, Stress-Free Solutions for Drug Discovery and Biologics
Validation of Bioanalytical Methods:
Validation of bioanalytical methods, particularly kinetic-based assays, is a cornerstone of generating accurate and reliable data in scientific research and pharmaceutical development. The validation process is designed to be both comprehensive and transparent, incorporating stringent checks and balances to ensure scientific robustness and ethical reporting. This involves a series of methodical steps, including the calibration of instruments, verification of assay sensitivity, specificity, precision, and accuracy, as well as the establishment of reproducibility and robustness under various conditions. By adhering to rigorous validation protocols, laboratories can contribute to the advancement of medical science and improve patient outcomes.
A critical component for maintaining data accuracy and security is the Octet? 21 CFR Part 11 Software package, which aligns with the FDA's 21 CFR Part 11 regulations. This software suite includes features such as an audit trail, electronic signatures, and robust electronic record-keeping, which are vital for deterring fraud and maintaining data integrity. Sartorius professionals handle the installation to ensure it is implemented correctly.
Regulation and Standards for Laboratory-Developed Tests:
The FDA underscores the importance of data integrity and has implemented a final rule to regulate laboratory-developed tests (LDTs) as medical devices. This regulation mandates that laboratories adhere to stringent standards of integrity and accuracy in their testing procedures. These measures are critical to ensuring patient safety and the reliability of medical devices, thereby maintaining high standards in the healthcare industry.
Further read:
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