_21-cfr-part-820-quality-system-regulation-applying-principles-of-lean-documents-and-lean-configuration.jpg "21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration from cots information technology Video Screenshot Preview")
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⏲ Duration: 5 min 13 sec
✓ Published: 03-Oct-2017
✓ Published: 03-Oct-2017
Description:
21 CFR Part 11 describes the quality standards required of all computer systems used in FDA-regulated industry. This regulation provides the basic framework for computer systems used to generate records and data used for analysis and presentation. However, it is important to remember that not only are technical controls but there are procedural controls as well. In this seminar, we will simplify the regulatory requirements and provide practical tips in creating standard operating procedures that
21 CFR Part 11 describes the quality standards required of all computer systems used in FDA-regulated industry. This regulation provides the basic framework for computer systems used to generate records and data used for analysis and presentation. However, it is important to remember that not only are technical controls but there are procedural controls as well. In this seminar, we will simplify the regulatory requirements and provide practical tips in creating standard operating procedures that
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