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CCPI Confidential Internal Audit Document 21 CFR 11 Electronic Records; Electronic Signatures Assessment Worksheet System Name: System Location: System ID #: System Owner: Assessment Type (check all.

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DocuSign offers modules to support your compliance with the electronic signature practices set forth in the U.S. Food and Drug Administration's 21 CFR Part 11. Our core Part 11 module includes Part 11-specific eSignature functionality for authentication, reason for signature, and signature manifestation.

Coverage. Practically speaking, Part 11 applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions.

INTRODUCTION. This guidance is intended to describe the Food and Drug Administration's (FDA's) current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).

In March of 1997, FDA issued final part 11 regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper.

Determine whether 21 CFR Part 11 applies to your company. Follow best practices in data protection and password security. Establish clear audit trails for traceability. Follow guidelines on electronic signatures. Do not outsource responsibility:you're in charge of 21 CFR Part 11 compliance. Validate for IQ, OQ, and PQ.

In other words, almost every medical device company must comply with 21 CFR Part 11 unless they truly do have everything on paper only, with no electronic copies of documents stored anywhere. Follow these tips to ensure the security and integrity of your records and you should be prepared for an FDA inspection.

(7) "Electronic record" means a record created, generated, sent, communicated, received, or stored by electronic means. (8) "Electronic signature" means an electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record.

FDA 21 CFR Part 11 compliance dictates that those companies who use electronic systems for document and signature control must provide assurance that the electronic documents are authentic. ... FDA 21 CFR Part 11 compliance dictates that signatures whether electronic or handwritten be linked to their respective records.

21 CFR Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, and/or transmitted under any records requirement set forth by the FDA.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232