Computerized System Validation: Be ready for audit!
By Steve McBraun
English | 2020 | ASIN: B08NT6XF3H | 57 pages | EPUB, MOBI | 7 MB
Based on many years of experience, an attempt was made to develop a standardized algorithm for analyzing and evaluating the current situation of the System with the subsequent determination of organizational and technical validation measures that will satisfy the relevant regulatory requirements in the long term.
The results of introspection will tell you what should be done to successfully pass the audit of the System, as well as collect the missing elements of a holistic picture - the Validated System.
This book is a kind of pocket guide to System Validation, which is designed to help expand the boundaries of understanding the current state of your System and identify gaps in the organization of the System lifecycle management process, as well as avoid blunders when conducting external audits.
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