What we solve for you
Whether you're preparing for an inspection, bringing a new system online, or qualifying a new supplier, the goal is the same: compliant, without slowing you down.
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Computer Software Validation & Assurance
Modern compliance for modern technology. Built to stand FDA and EMA scrutiny.
Includes
Computer Software Assurance (CSA)
Computer System Validation (CSV)
21 CFR Part 11 / Annex 11 Compliance
Cloud & SaaS System Validation
AI & Digital Validation Strategy
Data Integrity
Business Continuity and Disaster Recovery
What you getGAMP 5-aligned validation for clinical, quality, and manufacturing systems and CSV-to-CSA transitions handled with minimal business disruption.
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Quality Systems
Build quality into every stage of development.
Includes
Quality Management Systems (QMS)
SOP Development
Corrective & Preventive Actions (CAPA)
Risk Management
Training
Internal Audits
What you getFewer deviations and corrective actions after engagement, as reported by clients.
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Inspection Readiness
Confidence going into every audit and inspection.
Includes
FDA & EMA Inspection Preparation
Gap Assessments
Mock Inspections
Documentation Review
Supplier Audits & Vendor Qualification
Risk Assessment
What you getCompliance that holds up under review, with deliverables relied on in successful regulatory inspections.
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Strategic Quality Leadership
Experienced leadership when you need it.
Includes
Fractional Quality Leadership
Quality Strategy
Project Management
Continuous Improvement
Data Integrity Governance
What you getSenior quality expertise without the cost of a full-time hire.
"Scott is highly knowledgeable regarding computerized systems and adept at applying his knowledge to provide workable solutions. His insights and thoughtful recommendations have been key to our organization's journey towards compliance maturity."
— Lisa Y., Director, Quality Assurance, Private clinical-stage autoimmune disease biotech
