ForgeSOP CAPA
forgesop.com
What it is
ForgeSOP CAPA manages corrective and preventive actions from the initial issue through analysis, assigned work, approval, and a check that the remedy held. Deviations, audit findings, incidents, and risk treatments can open a CAPA linked to their source records. The analysis editor supports 5-Whys, fishbone, and free-form methods; evidence files are content-hashed to the record. Each corrective or preventive action can have an owner, due date, and verification criteria, and is tracked as an audit-trailed task. Closing requires a re-authenticated electronic signature, and an assessor cannot approve their own closure. A scheduled effectiveness check must confirm the fix held. A PDF binder 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, while noting that customers must validate formal Part 11 compliance. It runs on Android, iOS, and the web. Pro costs $7 a month, billed at $7 per user per month, and includes a 14-day trial; Enterprise pricing is custom.
Spec sheet
- Purpose
- ForgeSOP CAPA manages corrective and preventive actions with root-cause analysis, owned action plans, evidence, signatures, and effectiveness checks.Read 29 Sep 2026 · forgesop.com
- Intended users
- The maker positions ForgeSOP for teams running on process and identifies manufacturing, construction, retail, transportation and logistics, and utilities as industries.Read 29 Sep 2026 · forgesop.com
- Founded
- 2021Read 23 Sep 2026 · forgesop.com
- Action plans
- Corrective and preventive actions can have owners, due dates, and verification criteria, and each action is an audit-trailed task.Read 29 Sep 2026 · forgesop.com
- 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.Read 29 Sep 2026 · forgesop.com
- CAPA intake
- Deviations, audit findings, incidents, and risk treatments can open CAPAs linked to their source records.Read 29 Sep 2026 · forgesop.com
- 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.Read 29 Sep 2026 · forgesop.com
- Closure controls
- CAPA closure uses a re-authenticated e-signature and prevents an assessor from approving their own closure.Read 29 Sep 2026 · forgesop.com
- Company history
- ForgeSOP says it was founded in 2021 by two business owners and reports being trusted by 500+ businesses worldwide.Read 29 Sep 2026 · forgesop.com
- Data security
- ForgeSOP says database row-level security policies isolate tenant data, and identifies AWS, Cloudflare, Stripe, Resend, and Sentry as subprocessors.Read 29 Sep 2026 · forgesop.com
- Effectiveness
- A scheduled effectiveness check must confirm the fix held before the CAPA is truly closed.Read 29 Sep 2026 · forgesop.com
- Export
- The CAPA binder export combines intake, RCA, actions, signatures, and the hash chain in a PDF.Read 29 Sep 2026 · forgesop.com
- Root-cause analysis
- The RCA editor supports 5-Whys, fishbone, or free-form analysis, with evidence files content-hashed to the record.Read 29 Sep 2026 · forgesop.com
- 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.Read 29 Sep 2026 · forgesop.com
- 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].Read 29 Sep 2026 · forgesop.com
Plans and prices
Strong points and limits
Strong points
- CAPAs can link to deviations, audits, incidents, and risk treatments.
- Supports 5-Whys, fishbone, and free-form analysis.
- Actions include owners, due dates, and verification criteria.
- Closure requires a re-authenticated electronic signature.
- Available on Android, iOS, and web.
Limits
- No free plan is listed.
- Formal Part 11 compliance requires customer-side validation.
- Enterprise pricing is custom.
Who it suits
ForgeSOP positions the product for teams that run on process, including manufacturing, construction, retail, transportation and logistics, and utilities. It suits teams that need assigned actions, controlled sign-off, and effectiveness checks.
Verdict
ForgeSOP CAPA specifies a controlled path from intake to verified closure, with linked records, tracked actions, and a PDF binder. Teams should account for the customer validation requirement and the lack of a free plan.
Where Specifiction places it
- Corrective and Preventive Action Software#6 of 238.0