Scope
Define the product, process, or batch covered, including versions, locations, and excluded items. Scope prevents ambiguity during testing and limits the document's applicability in audits or contractual disputes.
A written Quality Assurance Document creates a single source of truth for expectations and verification, reduces rework, and provides evidence for audits and customer inquiries. It clarifies roles, shortens review cycles, and helps demonstrate compliance with internal policies and external regulations where applicable.
The document is prepared by quality teams, process owners, or project leads and shared with stakeholders who must verify compliance.
Stakeholders use the document for approvals, recordkeeping, and as the basis for corrective actions and continuous improvement.
The QA Manager is responsible for drafting the Quality Assurance Document, assigning test owners, and certifying that tests were executed. They sign to confirm completeness and to authorize release or corrective actions when acceptance criteria are met.
The Compliance Officer verifies that documented procedures satisfy regulatory and contractual requirements, signs to acknowledge review, and retains the document for audit purposes. Their signature signals organizational acceptance of controls and retention obligations.
Define the product, process, or batch covered, including versions, locations, and excluded items. Scope prevents ambiguity during testing and limits the document's applicability in audits or contractual disputes.
List measurable pass/fail criteria, tolerances, and thresholds. Use objective metrics and references to standards to remove subjective interpretation during inspections or approvals.
Describe test cases, sample size, methods, test data, and required tools. Include who performs tests and how results are recorded to support traceability.
Provide a defect classification, severity levels, and defect-resolution workflow. Link corrective actions to root-cause analysis and closure criteria to demonstrate remediation.
Assign owners for execution, review, approval, and escalation. Include contact details and signatory authority to avoid delays and unclear handoffs.
Record document version, change history, effective date, and approver signatures. Maintain archival copies to preserve auditability and historical decisions.
| Field | Configuration |
|---|---|
| Required Fields | Enforce title, version, effective date, owner, approver |
| Conditional Logic | Show corrective-action section only if defects are logged |
| Authentication | Use email or stronger methods for approvers |
| Notifications | Auto-notify reviewers and escalate overdue approvals |
Choose a platform that supports required fields, conditional logic, secure storage, and an immutable audit trail for approvals.
Ensure the platform can retain signed records, export an audit trail, and meet any industry compliance such as HIPAA or 21 CFR Part 11 where applicable.
7 calendar days from assignment
3–5 business days for technical feedback
Defined per test plan, often 1–14 days
10 business days recommended
Issue final signed document immediately after approvals
| 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 | 7-day free trial | Varies | Varies | Varies | Varies |
| Bulk Send | Yes (premium) | Yes | Yes | Yes | No |
| Audit Trail | Yes | Yes | Yes | Yes | Yes |
| HIPAA Compliant | Yes (BAA) | Yes | Yes | No | No |
| Envelope Cap | No cap | 100 envelopes/user/year | Varies | Varies | Varies |