Policy and SOP review, approval, and training evidence in one place.

Yes. ApprovaDoc is purpose-built for small medtech startups, SaMD companies, and ISO 13485-oriented teams that need documented SOP training records without full eQMS overhead. The workflow (assign by revision, acknowledge, verify comprehension, export for audit) is designed around what regulated device teams actually need to demonstrate during ISO 13485 and FDA inspections.

Yes. The underlying job is identical in any regulated or accredited operation: prove that a specific person acknowledged a specific revision of a controlled document on a specific date, and produce that evidence on demand. If your standard requires written directives or SOPs, documented periodic review, and proof that personnel acknowledged the current version, ApprovaDoc fits. Public safety communications, accredited labs, and quality-managed manufacturing all ask the same questions an ISO 13485 auditor does, in different vocabulary.

You configure reviewers and approvers for each document version. Reviewers add threaded comments and approve or reject. Approvers sign off sequentially with e-signatures when Part 11 is enabled, and the complete workflow, from submission through approval, is tracked in the audit trail. For documents reviewed and approved outside the system, such as externally authored ones, you can upload a pre-approved version with an audit justification and effective date. That upload is logged separately in the audit trail.

Each document version is assigned and acknowledged separately, so you always know who acknowledged which revision. When an SOP changes, upload the new revision and submit it for review and approval. Once it is approved and effective, everyone assigned the previous revision is reassigned automatically, and you can add more people when you publish it. Previous acknowledgments stay intact as immutable records, so auditors can see who read which revision and when, even across multiple document updates.

You can set a review interval (6 to 36 months) for any document. ApprovaDoc sends reminders at 30, 14, and 7 days before a review is due and records a formal sign-off when it is completed, either confirming no changes are needed or triggering a new revision. This supports ISO 13485 clause 4.2.4 requirements for regular document review.

Yes. You can attach an optional multiple-choice quiz to any document version. Team members must achieve a passing score before they can submit their acknowledgment. All quiz attempts, scores, and timestamps are recorded immutably, giving you documented evidence of comprehension verification, not just a checkbox.

Yes. Export acknowledgment records by document or date range with a single click. Exports include acknowledgment dates, revision numbers, and quiz scores if applicable. The training matrix view gives you an at-a-glance overview of who is current, overdue, or not yet assigned, which is exactly what auditors ask for.

Yes. Part 11 e-signatures are available on the Team and Growth plans. Signatures require re-authentication at signing time and are cryptographically bound to the specific record using HMAC, designed to support 21 CFR Part 11 requirements for electronic records and signatures. Contact info@approvadoc.com if you have specific questions about your compliance needs.

Not as a general file store. ApprovaDoc is specifically built for controlled SOP training workflows. It handles document review, approval, assignment, acknowledgment, reminders, and training evidence. If you currently track SOP training evidence in spreadsheets alongside SharePoint, ApprovaDoc replaces the spreadsheet and the manual follow-up, not the file storage.

No. Pricing is published on the website, checkout is fully self-serve, and the 14-day free trial requires no credit card. You can set up your organization, upload documents, and invite team members within minutes. If you have questions about fit for your specific compliance requirements, reach out at info@approvadoc.com, but there is no sales gate.