Title 21 CFR Part 11 helps life sciences companies establish security controls, workflows, audit trails, and checks to ensure the integrity, confidentiality, and authenticity of electronic records and signatures.
*Source: https://content.intland.com
To demonstrate Title 21 CFR Part 11 compliance, companies must:
*Source: https://www.fda.gov
Title 21 is the section of the Code of Federal Regulations that governs food and drugs within the U.S. for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP).
*Source: https://en.wikipedia.org
Delivering new products to market is challenging. And it is difficult to see the cost impact of one or more mistakes.
Try our calculator to estimate the impact on your business. Input your business details, select a challenge, and see the real-world cost impact as validated by our customers.