Scope
Define exactly which activities, locations, and systems are covered and what is explicitly excluded to prevent scope creep.
A written procedure reduces variability, supports audits, and documents accountability. It creates a clear chain of responsibility, helps meet legal and regulatory obligations, and provides a repeatable framework for training and continuous improvement under standards such as ESIGN and UETA.
Teams across operations, compliance, and finance use this procedure to align activity with policy and to document approvals.
Departments adopt and adapt the procedure to match local requirements while preserving the core approval, records, and audit-trail elements.
Typically a manager responsible for designing and maintaining the procedure. The Process Owner approves changes, monitors performance metrics, coordinates training, and is the primary contact during audits or incident investigations.
A counsel or compliance specialist who reviews the procedure for statutory risks, required disclosures, and retention rules. Legal ensures wording meets ESIGN/UETA standards and identifies when notarization or witness clauses are necessary.
| Field | Configuration |
|---|---|
| Approval Order | Sequential by role: owner > finance > legal |
| Authentication | Email link with optional SMS code or KBA |
| Notifications | Automated reminders after 48 hours |
| Archival | Store PDF/A with audit trail attached |
Choose a platform that supports required authentication, audit trails, and the file formats you use.
Ensure the solution meets compliance needs such as HIPAA, 21 CFR Part 11, or other industry requirements before enabling automatic routing.
Complete draft review within 14 business days.
Approvers should respond within 7 business days.
Reassess procedure at least every 12 months.
Revise within 30 days after a material incident.
Publish approved version within 3 business days.
Owner produces a complete draft with mapped steps and controls.
Stakeholders review for operational and compliance concerns.
Sign-off captured from process owner, finance, and legal.
Procedure published and staff training documented.
| signNow | DocuSign | Adobe Sign | PandaDoc | HelloSign | |
|---|---|---|---|---|---|
| Starting Price | $8/user/mo | $15/user/mo | $14/user/mo | $19/user/mo | $15/user/mo |
| Free Trial | Yes, 7-day trial | Varies by vendor | Varies by vendor | Varies by vendor | Varies by vendor |
| Bulk Send | Yes (Business Premium) | Yes | Yes | Yes | No |
| Audit Trail | Yes | Yes | Yes | Yes | Yes |
| HIPAA Compliant | Yes | Yes | Yes | No | No |
| Envelope Cap | No cap | 100 envelopes/user/year | Varies by plan | Varies by plan | Varies by plan |
Define exactly which activities, locations, and systems are covered and what is explicitly excluded to prevent scope creep.
List each role, responsibilities, and delegations of authority to ensure decisions are traceable and auditable.
Provide a step-by-step flow or swimlane diagram with inputs, outputs, and decision points for clarity.
Specify checks, approvals, and segregation of duties required to mitigate risk and satisfy auditors.
Define measurable performance indicators and reporting cadence to monitor process health and compliance.
Include version history, approver names, effective dates, and reason for each revision.