Electronic Signature Policy

1. Purpose

This policy outlines the requirements for using electronic signatures within SliceVault. It is designed to ensure compliance with applicable regulations such as 21 CFR Part 11 and the E-SIGN Act, and to confirm that electronic signatures are legally binding and equivalent to handwritten signatures.

2. Scope

The policy applies to all authorized users performing actions within the SliceVault platform that require an electronic signature.

3. Definition of an Electronic Signature

An electronic signature in SliceVault confirms the identity and intent of the user performing an action. It includes:

  • Login credentials (username and password)
  • A deliberate action by the user, such as clicking a sign button or re-entering a password
  • Binding the action to the associated record via a system-generated audit log

SliceVault’s e-signature functionality is designed to meet the requirements of:

  • 21 CFR Part 11 (Electronic Records and Signatures)
  • The E-SIGN Act (U.S. Electronic Signatures in Global and National Commerce)

5. User Responsibilities

Users are responsible for:

  • Keeping login credentials confidential
  • Ensuring that any signed action is accurate and intended
  • Not sharing or delegating signing access to others
  • Reporting any suspected misuse of their account to the Trial Administrator

6. E-Signature Use Cases

Electronic signatures are required for the following actions:

  1. Submitting data
  2. Changing visit status (e.g., during QC1, QC2, or reader review)
  3. Managing queries (opening, responding, closing, or reopening)
  4. Approving forms or documents
  5. Unlocking a form for editing

7. Authentication and Signature Requirements

For sensitive actions, SliceVault requires re-authentication. This means users must re-enter their password before signing actions such as data approval or form unlocking.

8. Binding Signatures to Records

Every e-signature is permanently linked to the corresponding record. The system logs:

  • The user’s full name and username
  • Role at the time of action
  • Timestamp
  • The action taken (e.g., Submit, Approve, Reject)
  • The selected reason for signing (where applicable)

9. Audit Trail

All electronically signed actions are recorded in a tamper-proof audit trail. This log includes a full, timestamped history of user actions and is available for internal or regulatory audit purposes.

10. First-Time Use Acknowledgment

Before using the e-signature feature, users must review and acknowledge this policy. The following message is displayed upon the first signing attempt:

Electronic Signature Notice By using the electronic signature system, you acknowledge that your e-signature is legally binding and equivalent to a handwritten signature. You are responsible for the accuracy of the actions you approve or submit. Misuse of this system may lead to disciplinary or legal consequences.

✅ I acknowledge and agree to the terms of using the electronic signature system.

This acknowledgment is recorded in the audit trail.

11. Non-Compliance

Any misuse or unauthorized use of the e-signature system may result in revoked access, disciplinary action (up to termination of the account), and potential legal consequences if fraud is involved.

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