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RiskGuard
Risk and quality management built on SAP S/4HANA
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RiskGuard - 2026 Pricing, Features, Reviews & Alternatives
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Last updated: October 2026
RiskGuard overview
What is RiskGuard?
RiskGuard is on-premise risk and quality management software for manufacturers that run SAP S/4HANA: medical devices, pharma, food and automotive suppliers.
SAP integration
- Reads plants, company codes, suppliers, customers, materials, purchasing info records, bills of material, batches, material documents and QM notifications through standard SAP OData APIs.
- Each QM notification becomes an incident with material, batch, supplier and severity (from the SAP priority) filled in.
- Root cause, corrective action and closure are written back to the SAP notification, and RiskGuard can create new quality notifications in SAP.
- Syncs run in the background, scheduled or on demand.
Risk analysis
- FMEA: process FMEA, design FMEA with block/boundary and P-diagrams, and FMEA-MSR; action priority, completeness checks, form export to PDF and Excel, and a control plan generated from the process FMEA.
- PHA, FTA, HAZOP and HACCP in the same system.
Quality management
- CAPA, complaints, change control, document control, training, internal and layered process audits, management review and KPIs.
- Supplier quality: qualification by material, supplier and site, supplier audits, questionnaires, requalification and a supplier risk heat map.
- PPAP, post-market surveillance and vigilance, design controls and design history file.
Security and compliance
- Runs in Docker containers on your own servers, with no cloud dependency.
- Single sign-on through OpenID Connect (Microsoft Entra ID, Okta, Google Workspace), TOTP multi-factor authentication and plant-level access rights.
- Short-lived access tokens with refresh-token rotation; SAP credentials stored encrypted.
- Electronic signatures and a SHA-256 hash-chained audit trail, supporting 21 CFR Part 11 and EU GMP Annex 11.
- Optional AI drafting uses an endpoint you choose (your own model or Azure OpenAI) and is off until you configure it.
Licensed per site, per organisation or per named user, with offline licence keys.
Starting price
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RiskGuard's key features
Most critical features, based on insights from RiskGuard users:
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RiskGuard pricing
Pricing plans
Pricing details:
Per User
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Per Site
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RiskGuard support options
Typical customers
Platforms supported
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RiskGuard FAQs
RiskGuard has the following typical customers:
Mid-size Business, Large Enterprises
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Q. What level of support does RiskGuard offer?
RiskGuard offers the following support options:
Email/Help Desk, Chat