For Pharma + Biotech + Medical Device Manufacturers
Pharma, biotech, and medical-device makers ship globally and inspect locally. FDA 21 CFR Part 11 + 210/211. EU Annex 11. ICH Q9 quality risk + Q10 pharmaceutical quality system. DSCSA Phase 2. EU MDR for devices. RiskWatch handles all of it as one survey-based assessment platform sized for QA, validation, and regulatory affairs teams.
Trusted by pharma + biotech + device makers managing FDA, EMA, MHRA, and Health Canada inspections across drug-product, API, biologic, generic, and device manufacturing sites.
Why Pharma QA Teams Pick RiskWatch
RiskWatch runs FDA 21 CFR Part 11, EU Annex 11, ICH Q9/Q10, DSCSA traceability, and EU MDR as one workflow on one platform, scored against the same controls library, and tracked through a single inspection-ready evidence trail. Built for QA + validation + regulatory affairs teams that face FDA Form 483s, EMA inspections, and audit observations from all three at once, without enterprise-bank GRC overhead.
Part 11 + Annex 11 system inventories live, with risk-based revalidation triggers tied to ICH Q9. URS, IQ, OQ, PQ evidence threaded into the same record.
Deviations, OOS, complaints, and CAPA tied to the controls they affect. ICH Q10 PQS evidence captured. Effectiveness checks tracked. Trends roll up to management review.
One QA Director, FDA + EMA + MHRA + Health Canada in scope. Pre-built libraries cut prep time. White-glove implementation in 30 days, not 6 months.
The Pharma Regulatory Landscape
FDA Form 483 observations cite the same data-integrity gaps cycle after cycle. The DSCSA Phase 2 stabilization period ended November 2024, with full enforcement now in effect. EU MDR implementation has driven device backlog into 2027. Part 11 was last meaningfully updated in 2003 but remains the most-cited regulation in 483s. Each region wants its own evidence package.
Three Domains, One Platform
RiskWatch covers all three. Each domain has a dedicated workflow, scoring model, and remediation queue. They share data so a single change-control event satisfies ICH Q9 risk assessment, Q10 PQS, Part 11 audit-trail review, and Annex 11 periodic review simultaneously.
Survey-based risk assessment across product quality, supply chain, validation, supplier, and process risk, scored against ICH Q9(R1) + Q10.
21 CFR Part 11, 21 CFR 210/211 cGMP, EU Annex 11, EU GMP Vol 4, ICH Q10, EU MDR, DSCSA in one cross-mapped library.
ALCOA+ data integrity, computerized-system cybersecurity, audit-trail review, and electronic-record controls aligned to NIST CSF + ISO 27001.
The Coverage Gap
EQMS platforms cover deviations + CAPA + change control. Validation tools cover Part 11. DSCSA serialization vendors cover traceability. Internal-audit tools cover SOX 404. Each does one job. Pharma QA teams still operate four parallel quality systems.
| Platform Category | Part 11 | Annex 11 | ICH Q9/Q10 | DSCSA | EU MDR | Multi-site |
|---|---|---|---|---|---|---|
| Pharma EQMS PlatformsVeeva Vault, MasterControl | Partial | Partial | Yes | · | · | Yes |
| Validation / CSV ToolsValGenesis, Kneat | Yes | Yes | · | · | · | Partial |
| DSCSA SerializationTraceLink, rfxcel | · | · | · | Yes | · | · |
| Internal Audit ToolsWorkiva, AuditBoard | Partial | Partial | · | · | Partial | · |
| EU MDR SpecialtyGreenlight Guru, Qualio | Partial | Partial | · | · | Yes | Partial |
| Spreadsheets & Email | · | · | · | · | · | · |
| RiskWatchThe unified inspection-ready platform | Yes | Yes | Yes | Yes | Yes | Yes |
RiskWatch is the only platform covering all six pharma compliance domains: 21 CFR Part 11 + Annex 11, 21 CFR 210/211 cGMP, ICH Q9(R1) + Q10, DSCSA, EU MDR/IVDR, and multi-site coordination. EQMS platforms cover deviations + CAPA. Validation tools cover Part 11 systems. DSCSA vendors cover serialization. Each does one job. RiskWatch unifies all six in one survey-based assessment workflow.
How It Works
RiskWatch is a survey-based assessment platform. The work is structured around questionnaires that capture quality, validation, supplier, and data-integrity evidence in a consistent format, then scored against every framework you align to.
For pharma, that workflow runs continuously across FDA 21 CFR Part 11, EMA Annex 11, ICH Q9(R1) + Q10, DSCSA, and EU MDR cycles. A single change-control record scores against Part 11, Annex 11, ICH Q9 risk assessment, and Q10 management review simultaneously. A single supplier qualification covers cGMP §211.84, ICH Q10 §2.7, and DSCSA authorized-trading-partner verification.
The same platform runs all of it, surfaces gaps before inspector arrival, assigns CAPA owners, and tracks effectiveness checks. Replace the four parallel tools and the spreadsheet bridge between them.
Built For Your Role
Owns the pharmaceutical quality system, FDA + EMA + MHRA inspection readiness, and ICH Q10 management review.
ICH Q10 PQS metrics live. Form 483 risk scored continuously. Inspector walks in to a current evidence package.Owns Part 11 + Annex 11 system inventory, URS/IQ/OQ/PQ documentation, and periodic revalidation.
Computerized system risk-tiered per GAMP 5. Revalidation triggers automated. Audit-trail review evidence captured.Owns FDA submissions, EU MDR technical files, EMA variations, and DSCSA verification network correspondence.
Submission-ready evidence packages on demand. Multi-region cross-reference live. Variation impact assessed in days.Owns CMO + CDMO + raw-material-supplier qualification, audits, and DSCSA authorized-trading-partner status.
Supplier scorecards live. Audit findings tracked to closure. DSCSA partner status surfaced before order release.Owns ALCOA+ posture, audit-trail review, electronic record controls, and data-integrity training.
ALCOA+ scoring per system. Audit-trail review evidence captured. Data-integrity gaps surfaced before inspection.Owns plant-level deviation, OOS, complaint, and CAPA workflows plus annual product review.
Deviation cycle time visible. CAPA effectiveness tracked. Annual product review built from live data, not spreadsheets.Built For Your Segment
Branded pharma with FDA + EMA + MHRA approvals running 21 CFR 211 cGMP across multi-site networks.
ANDA holders + 505(b)(2) sponsors managing high-volume API + finished-dose manufacturing under DSCSA.
BLA holders with cell-line, fill-finish, and biosimilar pipelines under FDA + EMA biologics guidance.
Third-party manufacturers running cGMP for sponsors with multi-client quality agreements + supplier audits.
Class II + III device makers under 21 CFR 820 QSR, EU MDR, IVDR, and ISO 13485.
Advanced therapy MAH/sponsors with chain-of-custody, donor eligibility, and FDA OTAT scrutiny.
Frameworks We Cover
RiskWatch ships with pre-built libraries for every major pharmaceutical, biotech, and medical-device regulation. Map controls once. Score against the framework that matters this audit cycle.
Trusted by FDA-regulated manufacturers
We retired five quality systems and the spreadsheets between them. Part 11 audit-trail review, Annex 11 periodic review, ICH Q9 risk assessments, DSCSA verification, supplier audits, all live, all cross-referenced. Our last FDA inspection produced one Form 483 observation instead of seven. Faster, smaller, cleaner.
Resources
Pharma · Biotech · Medical Devices
30-minute walkthrough of the FDA + EMA library, your inspection cycle inputs, and the single evidence-trail output. No slideware, no consulting upsell.
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