Currently browsing "Computer System Assurance"
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9 Tips To Comply with 21 CFR Part 11
For highly regulated medical device organizations and life science industries, it has become a challenge to achieve 21 CFR Part 11 compliance and a matter of concern for companies subjected to FDA inspections. Organizations must follow best practices in maintaining compliance and the quality process by following the 21 CFR Part 11 regulation. However, as […]
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The 3 Q’s in Computer System Validation – IQ OQ PQ
Adopting a Computer Systems Validation approach for the various systems they use is easier said than done when it comes to FDA-regulated organizations. Managing the computer system validation process is often comprehensive, with many steps from beginning to completion. Even one failure in the process can lead to devastating consequences for patients and the organization, […]
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FDA Transition to Computer System Assurance: The New CSV
The 2003 FDA guidance paved the road for implementation of efficient computer system validation for the pharmaceutical industry. Following that FDA guideline, the life science industry has become more efficient in validating computer systems and the documentation in order to comply with regulation, inspections, compliance, and audits. The FDA launched the Case for Quality in […]
