RiskWatch
RiskWatch International · Founded 1993 · Sarasota, FL, USA
Enterprise risk platform for pharma: one global register from threat to treatment, with KRI auto-escalation and ICH Q9(R1) quality risk management.
Summary
RiskWatch is an enterprise risk management platform built around a Global Risk Register that rolls quality, operational, IT, vendor, and physical risk up to a business-unit-to-enterprise view for the board. It runs a risk assessment engine with a KRI (Key Risk Indicator) library and auto-escalation when a risk breaches its threshold, a risk treatment workflow with owner assignment and tasks tracked to closure, and native threat and vulnerability libraries that feed risk scores; the assessment engine supports the ICH Q9(R1) Quality Risk Management process directly. Its differentiator is Risk-to-Compliance bi-directional mapping: audit findings flow back into risk scores and the register feeds control-assessment scope, so quality risk and GxP compliance are not two disconnected tools. Pre-built, cross-mapped control libraries for 40+ frameworks sit underneath, including 21 CFR Part 11 electronic records and signatures, 21 CFR Part 210 and 211 current Good Manufacturing Practice, 21 CFR Part 820 Quality Management System Regulation (QMSR effective February 2 2026), EU GMP Annex 11 computerised systems, EU GMP Annex 15 qualification and validation, ICH Q9(R1), ISO 13485 medical-device QMS, ISO 14971 medical-device risk management, ISPE GAMP 5 Second Edition alignment, and the HIPAA Security Rule. Customers include state Medicaid agencies, multi-hospital health systems, payers, medical device companies, and contract manufacturers. RiskWatch is sold quote-only, and single-tenant deployment keeps GxP data in the customer's control.
Strengths
- Global Risk Register consolidates quality, operational, IT, vendor, and physical risk into one register with business-unit-to-enterprise rollup for the board
- Risk assessment engine with a KRI (Key Risk Indicator) library and auto-escalation when a risk crosses its threshold; the engine supports the ICH Q9(R1) Quality Risk Management process directly
- Risk treatment workflow with owner assignment, tasks, and recommendations tracked to closure; site Quality Heads and validation engineers self-serve without a workflow-builder learning curve
- Risk-to-Compliance bi-directional mapping: audit findings flow back into risk scores and the register feeds control-assessment scope, so a single evidence item can satisfy FDA, EMA, and ISO 13485 audits (competitors usually split risk and compliance across two products)
- Native threat and vulnerability libraries plus heat maps and executive risk dashboards for board-ready reporting
- 40+ cross-mapped framework libraries sit underneath the risk layer, including 21 CFR Part 11, Part 210, Part 211, Part 820 QMSR, EU GMP Annex 11, ICH Q9(R1), and ISO 13485
- Vendor risk management supports supplier qualification, Quality Agreements, and continuous supplier monitoring required under 21 CFR 211.84 and EU GMP Chapter 5
- Physical security assessment module supports DSCSA serialisation site security and warehouse access controls aligned to GDP (Good Distribution Practice)
- 33-year operating history with federal customers (US Department of Defense, VA, DOJ per public press); single-tenant deployment with customer-owned data residency matters for GxP data under EU GMP Annex 11 and for FDA Part 11 audit-trail retention
Weaknesses
- Not a purpose-built electronic quality management system (eQMS) at the depth that MasterControl, Veeva Vault QMS, Sparta TrackWise Digital, or ETQ Reliance ship; we run the risk and assessment layer rather than a closed-loop deviation, CAPA, and change-control workflow
- No native DSCSA serialisation engine; pharma supply chain teams subject to 21 USC 360eee track-and-trace will still need a serialisation platform (TraceLink, rfxcel, SAP ATTP) underneath
- Pricing is quote-only with no public list price, so buyers must request a quote to size a deal
Pharmaceutical manufacturers, CDMOs, and biotechs that want one global register for quality, operational, IT, vendor, and physical risk, with KRI-driven escalation, treatment workflows, board-ready heat maps, and the ICH Q9(R1) quality risk process built in, plus 40+ framework compliance mapping (FDA cGMP, EU GMP, ISO 13485, HIPAA), supplier qualification, and Part 11 evidence with GxP data residency underneath.
Single-site sponsors whose only need is a closed-loop eQMS for deviations, CAPA, and change control; MasterControl, Veeva Vault QMS, or Sparta TrackWise Digital fit that brief better as primary workflow tools.
Key features
- Global Risk Register with business-unit-to-enterprise rollup
- Risk assessment engine with a KRI (Key Risk Indicator) library and threshold auto-escalation, aligned to the ICH Q9(R1) Quality Risk Management process (January 2023 revision)
- Risk treatment workflow with owner assignment, tasks, and recommendations tracked to closure
- Threat and vulnerability libraries that feed risk scores
- Heat maps, risk dashboards, and executive / board risk reporting
- Risk-to-Compliance bi-directional mapping (audit findings update risk scores)
- Pre-built, cross-mapped control libraries for 40+ frameworks including 21 CFR Part 11, Part 210 and 211 cGMP, Part 820 QMSR (effective February 2 2026), EU GMP Annex 11 and Annex 15, ICH Q9(R1), ISO 13485, ISO 14971, and GAMP 5 alignment
- Supplier qualification + Quality Agreement tracking aligned to 21 CFR 211.84 and EU GMP Chapter 5
- Physical security assessment module for DSCSA serialisation site security and GDP warehouse access controls
- Evidence vault with versioning and audit-ready export (FDA + EMA inspection pack); single-tenant deployment for GxP and HIPAA data residency
Integrations
25+ native. Notable: Microsoft Entra ID (SAML SSO), Okta, Microsoft 365 / SharePoint, Slack, Jira, Salesforce, Custom REST API.
Target size
100 to 50,000 employees · US · Canada · EU · UK · AU