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ForgeSOP CAPA
What ForgeSOP CAPA is
ForgeSOP CAPA manages corrective and preventive actions from issue intake through analysis, assigned work and checks that a fix held. Deviations, audit findings, incidents and risk treatments can open a CAPA linked to its source record. Its root-cause editor supports 5-Whys, fishbone or free-form analysis, with evidence files content-hashed to the record. Actions can include owners, due dates and verification criteria, and each is tracked as an audit-trailed task. CAPA closure requires a re-authenticated electronic signature, and an assessor cannot approve their own closure. A scheduled effectiveness check must confirm the fix held before closure. The PDF binder export combines 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 stating that customers must validate formal Part 11 compliance themselves. Pro costs $7 a month per user and includes a 14-day free trial; Enterprise pricing is custom. The product is available on Android, iOS and web.
Who it suits
ForgeSOP CAPA suits teams that manage quality issues through investigation, assigned corrective or preventive actions, and effectiveness checks. The maker identifies manufacturing, construction, retail, transportation and logistics, and utilities as intended industries.
What it does well
- Supports 5-Whys, fishbone and free-form analysis.
- Actions can include owners and verification criteria.
- Closure requires a re-authenticated electronic signature.
- Effectiveness checks are required before closure.
- Available on Android, iOS and web.
What to know first
- Formal Part 11 compliance requires customer-side validation.
- Enterprise pricing is custom.
- Pro is limited to 150 users.
Limits
Pro costs $7 per user per month and supports up to 150 users. Enterprise is for organizations above 150 users, has unlimited seats, and is custom priced. Formal Part 11 compliance requires customer-side validation.
Plans
| Plan | Billed and limits | Price |
|---|---|---|
| Pro | $7/ user / month · Up to 150 users · all features included · 14-day free trial | $7 a month |
| Enterprise | Custom; priced for your organization · Above 150 users · unlimited seats · all features included | On request |
As forgesop.com lists them, read 29 Sept 2026. The maker's own page has the final word.
Getting started
- Visit the ForgeSOP CAPA website.
- Choose Pro or contact ForgeSOP about Enterprise.
- Start a 14-day trial with Pro, or select Enterprise for an organization with more than 150 users.
- Use the web, Android, or iOS version to manage CAPAs.
Verdict
ForgeSOP CAPA links issue records to analysis, tracked actions, signed closure and an effectiveness check. Its Pro plan is $7 a month per user with a 14-day trial; confirm customer validation requirements if formal Part 11 compliance matters.
Questions
How much does ForgeSOP CAPA cost?
The Pro plan is $7 per user per month and includes a 14-day free trial. Enterprise is custom priced.
Is there a free plan?
No. ForgeSOP lists Pro and Enterprise as paid plans; Pro includes a 14-day trial.
What platforms can I use?
ForgeSOP CAPA is available on Android, iOS, and web.
Which root-cause methods does it support?
The RCA editor supports 5-Whys, fishbone, and free-form analysis.
Does ForgeSOP claim Part 11 compliance?
ForgeSOP describes its workflows as shaped for 21 CFR Part 11 requirements and says formal Part 11 compliance requires customer-side validation. Its trust page lists Part 11 as shape rather than certified.
What are the Pro and Enterprise plan limits?
Pro includes all features for up to 150 users. Enterprise is custom priced for organizations above 150 users and includes unlimited seats and all features.
Facts from ForgeSOP CAPA's own pages
- Action plans
- Corrective and preventive actions can have owners, due dates, and verification criteria, and each action is an audit-trailed task. · forgesop.com, 29 Sept 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, 29 Sept 2026
- CAPA intake
- Deviations, audit findings, incidents, and risk treatments can open CAPAs linked to their source records. · forgesop.com, 29 Sept 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, 29 Sept 2026
- Closure controls
- CAPA closure uses a re-authenticated e-signature and prevents an assessor from approving their own closure. · forgesop.com, 29 Sept 2026
- Company history
- ForgeSOP says it was founded in 2021 by two business owners and reports being trusted by 500+ businesses worldwide. · forgesop.com, 29 Sept 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, 29 Sept 2026
- Effectiveness
- A scheduled effectiveness check must confirm the fix held before the CAPA is truly closed. · forgesop.com, 29 Sept 2026
- Export
- The CAPA binder export combines intake, RCA, actions, signatures, and the hash chain in a PDF. · forgesop.com, 29 Sept 2026
- Founded
- 2021 · forgesop.com, 23 Sept 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, 29 Sept 2026
- Purpose
- ForgeSOP CAPA manages corrective and preventive actions with root-cause analysis, owned action plans, evidence, signatures, and effectiveness checks. · forgesop.com, 29 Sept 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, 29 Sept 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, 29 Sept 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, 29 Sept 2026