Get 21 Cfr 11 - Electronic Records Electronic Signatures

Filling out the 21 CFR 11 assessment worksheet for electronic records and signatures is essential for compliance with regulatory standards. This guide provides clear instructions to help users complete the form efficiently and accurately.

Follow the steps to successfully fill out the assessment form online.

1. Click the ‘Get Form’ button to obtain the assessment worksheet and open it in the editor of your choice.
2. Fill in the general information fields including System Name, System Location, System ID #, and System Owner.
3. In the Assessment Type section, check all applicable boxes including Electronic Records, Electronic Signatures, Closed System, and Open System as needed.
4. Document the Start Date and indicate the names of the Assessor(s) involved in the evaluation.
5. Complete the System Classification Section by responding to the questions regarding system compliance with 21 CFR 11.
6. Using Table 1, identify applicable sections of 21 CFR 11 for the assessed system and mark non-applicable items as 'N/A' in the Assessment Section.
7. Assess each section in the Assessment Section by marking results as ‘C’ for Conforming, ‘NC’ for Non-conforming, or ‘N/A’ for Not Applicable.
8. Provide comments or recommendations in the Observations Section for each Non-conformance or Not Applicable result.
9. Once completed, ensure all sections are filled correctly and make the necessary approvals by signing in the Approval section.
10. Finally, save changes, download, or print the completed assessment worksheet for your records or share it with relevant parties.

Start compiling your 21 CFR 11 assessment online to ensure compliance with electronic records and signatures.