Currently browsing "Computer System Assurance"
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9 Tips To Comply with 21 CFR Part 11
For highly regulated medical device companies and life science industries, it has become a challenge to achieve 21 CFR Part 11 compliance and a matter of concern for the companies who are subjected to FDA inspections. Organizations are required to follow best practices for maintaining the compliance and quality process by following the 21 CFR […]
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The 3 Q’s in Computer System Validation – IQ OQ PQ
When it comes to the FDA regulated businesses, the industries always follow the Computer System Validation approach. Managing the computer system validation process is often a comprehensive process with many steps to completion. Even one failure in the process can lead to devastating consequences for patients, as well as the company who can face warning […]
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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 […]
