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Enabling CFR Part 11 Compliance in ClientPoint Sign

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Elayza Cataluna
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Overview: What is CFR Part 11 Compliance in ClientPoint Sign?
CFR Part 11 compliance in ClientPoint Sign provides an added layer of security through double authentication, ideal for high-stakes documents such as contracts, agreements, and healthcare proposals. With the CFR Part 11 configuration, signers receive a unique verification code each time they sign, ensuring each signature is fully authenticated. This feature helps companies maintain a higher level of control and compliance, particularly important in industries with strict regulatory requirements.

Benefits of CFR Part 11 Compliance in ClientPoint Sign

  • Double Authentication for Enhanced Security: Ensures that each signature is verified with a secure code, reducing risks associated with unauthorized access.
  • Streamlined Compliance for Sensitive Documents: Ideal for healthcare and other regulated industries requiring CFR Part 11 compliance.
  • Seamless Process: Adds security without altering the signing experience, allowing for a straightforward and safe document-signing process within the ClientPoint platform.

How to Enable CFR Part 11 Compliance for ClientPoint Sign

  1. Login to ClientPoint
    Start by logging into your clientpoint.net Experience or admin account.

  2. Access Advanced Settings

    • From the Home page, click on Settings.
    • Navigate to Advanced Settings. This menu allows Administrators to adjust global settings for their ClientPoint account.

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Enable CFR Part 11 Compliance

    • Scroll down to Signature Configuration under Advanced Settings.

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    • Ensure that ClientPoint Sign is enabled, then toggle on 21 CFR Part 11 Compliance.
    • Click Save to confirm.

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Setting Up a Document for CFR Part 11 Compliance Signing

  1. Choose or Create a ClientPoint

    • Select an existing ClientPoint or create a new one with documents requiring CFR Part 11 compliance.

  2. Add Document for Signature

    • Open the Files tab within the selected ClientPoint.
    • Add the document from the Content Library or click Add to ClientPoint to upload directly from your drive.

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  1. Enable eSign and Prepare Document for Signature

    • With the document selected, click Enable eSign to open the Easy Signature document builder.
    • Enter the total number of signers required, then click Continue. 

    • To ensure that customers, particularly those requiring FDA compliance, can streamline their eSign processes, we recommend setting up eSign with ClientPoint tags. Tags allow you to customize document fields, making the signing experience more efficient and compliant with regulatory standards.

      For step-by-step guidance, read more about ClientPoint Tags here.

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    • Drag and drop required fields (Text Areas, Checkboxes, Dates, and Signature Blocks) for each signer. Click Settings to adjust form fields as needed.

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  1. Complete Signature Setup

    • Once fields are set, click Continue to process the document. A message will indicate when the document is ready for signing.

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Signing Process with CFR Part 11 Authentication

  1. Initiate Signing

    • Signers can begin signing by navigating to the Preview tab and clicking Start Signing.

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  1. Verify Each Signature with a Code

    • Upon initiating a signature, signers receive a verification code via email. They must enter this code to proceed.

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    • After signing, another verification code will be sent, which signers must enter to finalize and save the signature.

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  1. Receive Signed Document and Signature Certificate

    • Once all required parties have signed, ClientPoint generates an email notification to all signers, indicating that the document is ready for viewing and download.

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    • The signed document includes a Signature Certificate, recording the signing activity and timestamp for each participant. Users can download this certificate along with the signed document.

FDA Signature Cert.png

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The CFR Part 11 feature in ClientPoint Sign ensures the highest security standards, making it invaluable for sensitive transactions across industries.

For any questions, please email us at support@clientpoint.net.