SOP Review & Approval Software
SOP Review & Approval Software for Small Regulated Teams
Route documents through configurable review and approval workflows with threaded comments, sequential phases, and Part 11 e-signatures. Built for medtech teams that need audit-ready approval evidence.
SOP review and approval is still done over email
Most small regulated teams have no structured workflow for document review and approval — decisions are scattered across inboxes with no audit trail.
Common pain points
- SOP review and approval tracked via email with no audit trail
- Approvals scattered across email threads and SharePoint comments
- No way to prove who approved which version and when
- Review cycles take weeks because there is no structured workflow
Until an audit asks
- Who reviewed and approved this SOP version?
- When was the approval decision recorded?
- Were e-signatures captured for this approval?
- Can you show the review comments and decisions?
- Was the approval completed before the document was distributed?
From draft to approved in a structured workflow
A clear review and approval process with full traceability.
Upload and submit for review
Upload the SOP and select reviewers. The version enters In Review status.
Reviewers comment and decide
Reviewers add threaded comments and approve or reject the version.
Route through approval
After all reviewers approve, approvers are notified. Sequential phases with e-signatures.
Make effective or schedule
Set an immediate effective date or schedule for a future date.
Assign training
Effective versions can be assigned for acknowledgment with optional quizzes.
Review and approval features for regulated teams
Structured workflows with threaded comments, e-signatures, and immutable audit trails.
Document review workflow
Configure reviewers per version. Threaded comments, approve or reject decisions, and a full audit trail.
Document approval workflow
Configure approvers with sequential phases. E-signature support when Part 11 is enabled.
Version lifecycle tracking
Each version moves through Draft, In Review, Approved, Effective, and Superseded states.
Scheduled effective dates
Set a future effective date after approval. The version transitions to Effective automatically.
Change summary per version
Document what changed in each revision. Supports ISO 13485 clause 4.2.4(c) requirements.
Controlled SOP register
Track document ID, title, owner, effective date, revision, and version status. Upload pre-approved documents with audit justification.
Audit log
Maintain a clear history of review decisions, approvals, assignments, acknowledgments, and exports.
Exportable evidence pack
Download audit-ready records with assignment, acknowledgment, and revision history.
Built from real audit experience
ApprovaDoc comes from direct experience developing medical devices, navigating ISO 13485 and FDA audits, and working inside quality systems that ranged from excellent to barely functional. Training evidence deserves focused tooling — not a module buried inside an overbuilt system.
Regulated industry experience · Purpose-built for small teams
Learn why we built this →SOP review & approval — common questions
Replace email-based SOP approvals with a structured workflow
Start your free trial and route your first document through review and approval in minutes.
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