eBook

Life sciences: ensuring the integrity & authenticity of your electronic records

March 29, 2016

Life sciences: ensuring the integrity & authenticity of your electronic records

Today, as life sciences organizations digitize both documentation and training, they must address increasing pressures to maintain compliance with many global regulations. For example, The Food and Drug Administration (FDA) mandates through 21 CFR Part 11 that life sciences organizations ensure the authenticity of electronic records and signatures, including training records. Noncompliance has significant consequences, including the risk of regulatory inspections and damage to the integrity and reputation of the organization itself.Today, as life sciences organizations digitize both documentation and training, they must address increasing pressures to maintain compliance with many global regulations. For example, The Food and Drug Administration (FDA) mandates through 21 CFR Part 11 that life sciences organizations ensure the authenticity of electronic records and signatures, including training records. Noncompliance has significant consequences, including the risk of regulatory inspections and damage to the integrity and reputation of the organization itself.