The Role of Information Systems in Title 21 CFR Part 11 Compliance: What You Should Know

March 31, 2011

As regulatory compliance requirements continue to rise for life sciences companies, the need for comprehensive record keeping is becoming more acute. Fortunately, electronic record keeping and management systems can greatly facilitate the speed, accuracy, and ease with which mandated documentation can be kept and retrieved for the FDA and other regulatory agencies.

Using electronic records instead of paper records greatly increases the speed and efficiency of the regulatory compliance process, making it easier to identify trends and inconsistencies, reducing mistakes due to human error, and facilitating data analysis.
This important white paper provides an overview on Title 21 CFR Part 11 and how to deploy enabling technologies to achieve compliance, including the use of electronic record keeping and electronic signatures.

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