For Pharma + Biotech + Medical Device Manufacturers
An inspector can arrive at any site, and one broken audit trail or one stale validation is how a Form 483 turns into a warning letter that halts a product line. Most quality teams run validation, quality events, supplier qualification, and data integrity as separate systems, so when the inspector asks, the evidence has to be assembled instead of shown. RiskWatch runs all of it as one program: score every site against one control library, link every deviation and CAPA to the controls it touches, and produce an inspection-ready package on demand. (Covers FDA 21 CFR Part 11 + 210/211, EU Annex 11, ICH Q9 + Q10, DSCSA Phase 2, and EU MDR for devices, with ALCOA+ data integrity throughout.)
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 gives QA, validation, and regulatory affairs one program that holds the evidence an FDA or EMA inspector asks for, current and cross-referenced, instead of scattered across separate quality systems. Validation state, quality events, supplier qualification, and data integrity run on the same record, so a single change control answers every regulator at once and overdue reviews surface before the inspector finds them. (One library spans FDA 21 CFR Part 11, EU Annex 11, ICH Q9/Q10, DSCSA traceability, and EU MDR, without enterprise-bank GRC overhead.)
System inventories stay live, with risk-based revalidation triggers that fire before a system goes stale, and URS, IQ, OQ, and PQ evidence threaded into the same record. (Part 11 + Annex 11 inventories, revalidation tied to ICH Q9.)
Deviations, OOS results, complaints, and CAPAs link to the controls they affect, with effectiveness checks tracked and trends rolling up to management review. (ICH Q10 PQS evidence captured throughout.)
One QA Director keeps FDA, EMA, MHRA, and Health Canada in scope, with pre-built libraries that cut prep time. Live 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 500+ risk and compliance teams
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.
Or call US: +1 941-500-4525
