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.

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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?

Why document approval must be traceable

ISO 13485 clause 4.2.4(a) requires that documents are approved for adequacy prior to issue. This means the approval must be documented — with evidence of who approved, when, and in what capacity — before the document is distributed for training. Email-based approval processes rarely produce this evidence in a structured, retrievable form.

After a document is approved and becomes effective, it can be assigned for training. This creates a natural connection between document approval and SOP acknowledgment records: every acknowledgment is tied to an approved, effective revision. For teams managing broader document control for medtech, the approval workflow sits within the full SOP lifecycle alongside periodic review, training, and audit-ready exports. When approvals include electronic signatures, 21 CFR Part 11 electronic record requirements apply.

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.

A note from the team

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.

— the ApprovaDoc teamLearn why we built this →

Common questions

SOP review & approval — common questions

How does review differ from approval?

Review is the first phase — subject matter experts read the document, add threaded comments, and approve or reject. Approval is the second phase — approvers are notified only after all reviewers approve. Both phases are tracked separately in the audit trail.

Can I configure different reviewers and approvers for each version?

Yes. When you submit a version for review, you select the specific reviewers and approvers for that version. Different documents can have completely different review teams.

Are e-signatures required for approval?

E-signatures are available on the Team and Growth plans when Part 11 mode is enabled. Without Part 11, approvers still submit formal decisions that are recorded immutably — e-signatures add password re-authentication and cryptographic binding.

What happens if a reviewer rejects?

The version moves to Rejected status and the author is notified. The author can then recall the version to Draft, make changes, and resubmit with new or updated reviewers.

Can I skip review for some documents?

Yes. You can upload a pre-approved document with an audit justification and effective date. This is useful for externally authored documents that were reviewed outside ApprovaDoc.

How does this compare to email-based approvals?

Email approvals have no audit trail, no status tracking, no threaded discussion, and no proof of who approved what. ApprovaDoc records every decision immutably with timestamps, comments, and optional e-signatures.

Lightweight Document Control for Medtech

Review, approve, distribute, train, and periodically review SOPs — without a full eQMS.

SOP Periodic Review Software

Set review intervals, get automatic reminders, and record formal periodic review sign-off.

SOP Training Records Software

Track SOP training records with revision-specific acknowledgments and audit-ready exports.

Trust, Security & Validation

How ApprovaDoc handles data security, audit trail integrity, and regulatory compliance.

ApprovaDoc vs Full eQMS

When you need document control and training evidence but not a full quality management system.