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ForgeSOP CAPA
What it is
ForgeSOP CAPA manages corrective and preventive actions from the originating issue through investigation, assigned work, and a check that the remedy was effective. Deviations, audit findings, incidents, and risk treatments can each open a CAPA connected to their source record. For root-cause analysis, users can choose 5-Whys, fishbone, or a free-form approach; evidence files are content-hashed to the record. Action plans can include owners, due dates, and verification criteria, and each action is tracked as an audit-trailed task. Closing requires a re-authenticated e-signature, and an assessor cannot approve their own closure. A scheduled effectiveness check must confirm the fix held before the CAPA is fully closed. The PDF binder export brings together intake, analysis, actions, signatures, and the hash chain. ForgeSOP describes workflows shaped for ISO 9001 §10.2, ISO 13485, and 21 CFR Part 11 requirements, while noting that customers must validate formal Part 11 compliance. Android, iOS, and web access are available. The Pro plan is $7/user/mo, with a 14-day trial; Enterprise pricing is custom.
For and against
For
- Choose 5-Whys, fishbone, or free-form analysis.
- Actions can include owners and verification criteria.
- Re-authenticated e-signature required for closure.
- Available on Android, iOS, and web.
Against
- No free plan is listed.
- Formal Part 11 compliance requires customer-side validation.
- Enterprise pricing is custom.
The verdict
ForgeSOP CAPA ties investigation, action tracking, signatures, and effectiveness checks into a documented closure workflow. The listed starting price is $7/user/mo, and formal Part 11 compliance is not certified by the maker.
Who it suits
It suits teams that manage quality actions across manufacturing, construction, retail, transportation and logistics, or utilities. Teams needing mobile access or an effectiveness check before closure may find its workflows relevant.
Plans and prices
Pro
Up to 150 users · all features included · 14-day free trial
Read 29 Sep 2026 · forgesop.com
Enterprise
Above 150 users · unlimited seats · all features included
Read 29 Sep 2026 · forgesop.com
On the record
- Action plans
- Corrective and preventive actions can have owners, due dates, and verification criteria, and each action is an audit-trailed task.forgesop.com · read 29 Sep 2026
- Audit trail
- The maker says state changes are stored in an append-only, hash-chained ledger and exported PDFs include a chain head and verifier description.forgesop.com · read 29 Sep 2026
- CAPA intake
- Deviations, audit findings, incidents, and risk treatments can open CAPAs linked to their source records.forgesop.com · read 29 Sep 2026
- Certifications
- The trust page lists SOC 2 Type II and ISO 27001 as roadmap items, Part 11 as shape rather than certified, and GDPR as compliant.forgesop.com · read 29 Sep 2026
- Closure controls
- CAPA closure uses a re-authenticated e-signature and prevents an assessor from approving their own closure.forgesop.com · read 29 Sep 2026
- Company history
- ForgeSOP says it was founded in 2021 by two business owners and reports being trusted by 500+ businesses worldwide.forgesop.com · read 29 Sep 2026
- Data security
- ForgeSOP says database row-level security policies isolate tenant data, and identifies AWS, Cloudflare, Stripe, Resend, and Sentry as subprocessors.forgesop.com · read 29 Sep 2026
- Effectiveness
- A scheduled effectiveness check must confirm the fix held before the CAPA is truly closed.forgesop.com · read 29 Sep 2026
- Export
- The CAPA binder export combines intake, RCA, actions, signatures, and the hash chain in a PDF.forgesop.com · read 29 Sep 2026
- Intended users
- The maker positions ForgeSOP for teams running on process and identifies manufacturing, construction, retail, transportation and logistics, and utilities as industries.forgesop.com · read 29 Sep 2026
- Purpose
- ForgeSOP CAPA manages corrective and preventive actions with root-cause analysis, owned action plans, evidence, signatures, and effectiveness checks.forgesop.com · read 29 Sep 2026
- Root-cause analysis
- The RCA editor supports 5-Whys, fishbone, or free-form analysis, with evidence files content-hashed to the record.forgesop.com · read 29 Sep 2026
- Standards
- The maker describes the workflows as built for ISO 9001 §10.2, ISO 13485, and 21 CFR Part 11-shaped requirements, and says formal Part 11 compliance requires customer-side validation.forgesop.com · read 29 Sep 2026
- Support and agreements
- The maker lists DPA availability on Professional and Enterprise, MSA on Enterprise, and a BAA on Enterprise; it directs agreement requests to [email protected].forgesop.com · read 29 Sep 2026
