Process Validation Consulting & Training
Risk-Based Validation Made Practical
Plan and execute validation that stands up to audits: Planning → IQ/OQ/PQ → PPQ → Monitoring → Revalidation.
USQC aligns your validation with FDA 21 CFR 820.75, ISO standards, GAMP 5, and EU Annex 11 — without unnecessary bureaucracy.
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What You Get
- Gap assessment & risk ranking (FMEA/FTA compatible)
- Validation Master Plan & Protocols (IQ, OQ, PQ, PPQ)
- Sampling rationale & statistical templates
- Digital tool coverage (Excel, SAP, e-signatures, LIMS)
- Auditor-ready reports & dashboards
- Onsite or remote coaching and workshops
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Who It’s For
- Medical device & pharmaceutical manufacturers
- Healthcare & diagnostic labs
- Food, packaging, and industrial manufacturing
- Teams validating spreadsheets, SAP workflows, or electronic signature systems
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Business Outcomes
- Compliant processes that pass audits with confidence
- Reduced deviations and fewer costly investigations
- Faster technology transfers and smoother change control
- Clear traceability from requirements → testing → final report
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Why USQC
- Risk-based, right-sized documentation
- Hands-on mentoring for your staff
- Global delivery: remote or onsite
- Templates that cut preparation time by 40–60%
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The Validation Lifecycle
- Plan – Define scope, requirements, CQAs/CPPs, and risks. Create sampling strategies.
- IQ (Installation Qualification) – Verify setup, calibration, utilities, access, and baselines.
- OQ (Operational Qualification) – Challenge operating ranges, alarms, and failure modes.
- PQ (Performance Qualification) – Show performance under normal operating conditions.
- PPQ (Process Performance Qualification) – Demonstrate capability in routine use with statistical justification.
- Monitor & Revalidate – Trend performance, use control charts, and trigger partial or full revalidation as needed.
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Training Programs
- Instructor-Led Workshops (customized to your team) cover:
- Validation fundamentals & regulatory drivers (FDA 21 CFR 820.75, ISO, Annex 11, GAMP 5)
- Sampling plans & statistical justifications
- Authoring validation plans, protocols, and reports
- Case studies: Excel spreadsheet validation, SAP transactions, and e-signature workflows
Formats Available:
2-hour clinics
1-day bootcamps
2-day deep dives
Fully customized programs
Deliverables Include:
- Risk assessments and Validation Master Plans
- IQ/OQ/PQ/PPQ protocols with templates
- Sampling calculators and deviation logs
- Final reports and monitoring dashboards
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Common Pitfalls We Help Avoid
- Arbitrary PPQ runs without statistical rationale
- OQ testing limited to “happy path” only
- Uncontrolled spreadsheets or macros
- Weak deviation and root-cause handling
- Missing links from risks → tests → acceptance criteria
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Regulatory Alignment
- FDA 21 CFR 820.75 (Process Validation)
- GAMP 5 and Annex 11 for computerized systems
- ISO 13485 / ISO 9001 quality management principles
- Computer Software Assurance (CSA) risk-based approach
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Ready to Validate With Confidence?
USQC helps organizations create right-sized, audit-ready validation packages. Book a discovery call with our experts and learn how our consulting, training, and templates can accelerate compliance and reduce risks.
📞 Contact us today at admin@usqc.us or through our contact form.
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FAQs
How long does a typical engagement take?
Rapid assists take 1–2 weeks for planning and protocols. Full lifecycle support depends on complexity, sampling needs, and number of PPQ runs.
Do you support hybrid (process + software) validation?
Yes — we cover both equipment and enabling software like spreadsheets, SAP, LIMS, and e-signature systems.
Can you train auditors and engineers together?
Absolutely. Cross-functional workshops improve adoption, documentation quality, and monitoring discipline.
Will you customize templates for our QMS?
Yes. All templates are tailored to fit your quality management system and terminology.
