Considerations When Validating Your Analyst® Software
White Paper Jan 24, 2012
The FDA considers software validation to be “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.”1 Note the terms “objective evidence” and “particular requirements.” Confirmation of conformity to user needs and intended uses is obtained by comparing actual system performance to pre-determined requirements.
Validation, in the context of government regulation, is distinct from hardware Installation Qualification/Operational Qualification/Instrument Performance Verification (IQ/OQ/IPV).
The purpose of the validation project is to document that the decisions made regarding the system have been properly designed, documented, executed, and verified. It is important to demonstrate that actions were properly planned, that the actions were executed according to the plan, and that the correct records have been kept.
The purpose of this white paper is to assist users in validating their Analyst® Software.
Related White Papers
Big Data Lipidomics for Lipid Biomarker Identification and Drug DiscoveryWhite Paper
Data analysis process aiming at the identification of lipid biomarkers and the
evaluations of their performance.
Biophysical Application of Calorimetric Methods to Protein Misfolding and Aggregation ExaminationsWhite Paper
Promoting calorimetry-based studies on protein misfolding by developing treatments and prevention of aggregation-related diseases.READ MORE
Analytical Characterisation of Mouthfeel in ChocolateWhite Paper
The particle size and rheology of the chocolate are critical factors in determining and predicting mouthfeel.READ MORE
10th Edition of International Conference on Structural Biology 2018
Mar 15 - Mar 17, 2018