Validation Services Built for Regulatory Scrutiny
Every engagement is executed with the rigor of a formal validation protocol — documented, defensible, and designed to withstand FDA inspection.
FDA 21 CFR Part 11 · EU Annex 11 · GAMP 5
Computer System Validation (CSV)
Computer System Validation (CSV) is the documented process of demonstrating that a GxP-critical software system consistently performs as intended and meets all applicable regulatory requirements. Our CSV engagements follow the GAMP 5 software categorization model and align with FDA 21 CFR Part 11, EU Annex 11, and current industry best practices.
Key Deliverables
- Validation Master Plan (VMP)
- User Requirements Specification (URS)
- Functional and Design Specifications review
- Risk Assessment (GAMP 5 Category 3/4/5)
- Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols and reports
- Traceability Matrix
- Validation Summary Report
Applicable Systems & Scope
- Laboratory Information Management Systems (LIMS)
- Manufacturing Execution Systems (MES)
- Enterprise Resource Planning (ERP) systems
- Chromatography Data Systems (CDS)
- Electronic Batch Record (EBR) systems
- Building Management and Environmental Monitoring Systems
cGMP · USP · FDA Process Validation Guidance
Equipment Qualification (IQ/OQ/PQ)
Equipment qualification is the cornerstone of cGMP compliance for pharmaceutical and biotech manufacturing. Our IQ/OQ/PQ services provide the documented evidence that equipment is installed correctly, operates within defined parameters, and consistently produces results meeting predetermined specifications.
Key Deliverables
- Installation Qualification (IQ) — verification of correct installation per manufacturer specifications and design intent
- Operational Qualification (OQ) — demonstration that equipment operates within defined limits across its operating range
- Performance Qualification (PQ) — evidence that equipment consistently performs under actual or simulated production conditions
- Equipment qualification protocols and final reports
- Calibration and preventive maintenance integration
- Change control and requalification support
Applicable Systems & Scope
- Analytical instruments (HPLC, GC, UV/Vis, Karl Fischer)
- Sterilization equipment (autoclaves, dry heat ovens)
- Environmental chambers and stability storage units
- Filling and packaging equipment
- Clean utilities (WFI systems, clean steam generators)
- HVAC and cleanroom systems
Electronic Records · Electronic Signatures · Audit Trails
21 CFR Part 11 Compliance
FDA 21 CFR Part 11 establishes the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. Non-compliance is among the most frequently cited issues in FDA warning letters. Our Part 11 services address both the technical controls and procedural requirements that regulators expect.
Key Deliverables
- 21 CFR Part 11 gap assessment against current system configuration
- Audit trail review and configuration verification
- Electronic signature controls assessment
- Access controls and user management review
- Remediation roadmap and implementation support
- SOP development for electronic records management
- Inspection readiness review
Applicable Systems & Scope
- LIMS and CDS platforms
- Electronic batch record systems
- Quality management systems (QMS)
- Document management systems (DMS)
- Process control and SCADA systems
ICH Q10 · GMP · GLP · GDP
GxP Documentation & Audits
Robust GxP documentation is the foundation of regulatory compliance. Poorly written or incomplete validation documentation is a primary driver of FDA 483 observations and warning letters. We develop, review, and remediate the full spectrum of validation and quality documentation — written to regulatory standards, not just internal templates.
Key Deliverables
- Validation Master Plans and Site Validation Plans
- Standard Operating Procedures (SOPs) for validation activities
- Risk assessments (FMEA, risk ranking and filtering)
- Change control documentation and impact assessments
- Periodic review and revalidation support
- Pre-inspection documentation audits
- Mock FDA inspection preparation
Applicable Systems & Scope
- Pharmaceutical manufacturing (GMP)
- Laboratory operations (GLP)
- Distribution and supply chain (GDP)
- Clinical operations (GCP)
Protocol-Grade Rigor on Every Engagement
We do not use generic templates. Every validation deliverable is authored to the specific system, equipment, and regulatory context of your facility — written to survive an FDA inspection, not just satisfy an internal checklist.
Risk-Based
All validation activities are scoped using formal risk assessment, ensuring effort is proportional to GxP criticality.
Lifecycle Approach
Validation is treated as a continuous lifecycle — from initial qualification through change control and periodic review.
Audit-Ready
Every deliverable is authored with the expectation that an FDA investigator will read it. Clarity, traceability, and completeness are non-negotiable.
Need Validation Support?
Tell us about your system, equipment, or compliance challenge — we'll outline a validation approach tailored to your regulatory context.