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Simplifying your FDA 21 CFR 11 Compliance Program

Simplifying your FDA 21 CFR 11 Compliance Program

The United States government, Department of Food and Drug Administration (FDA) established a regulation dealing with guidelines on Electronic Records and Electronic Signatures, known as the FDA 21 CFR 11. This regulation defines the criteria under which the agency (FDA) considers electronic records, electronic signatures, and hand-written signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and hand-written signatures executed on paper. The Regulation and subsequent amendments apply to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations, and also extend to electronic records submitted to the agency.

HCL recognizes regulatory compliance as a practical roadmap for improving business value. Organizations are increasingly burdened with the number of regulations, the work effort required to comply and the growing costs of managing compliance initiatives. HCL specializes in optimizing compliance efforts by implementing streamlined processes and leveraging people & technology driven process automation to transform ad-hoc compliance activities into a manageable and comprehensive compliance program.

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We will treat any information you submit with us as confidential. Please read our privacy statement for additional information.