Commissioning, Qualification & Validation
We provide lifecycle commissioning, qualification, and validation services to help regulated manufacturing systems meet technical, quality, and compliance requirements.
JC Automation supports the complete commissioning, qualification, and validation lifecycle for pharmaceutical and life science manufacturing systems and equipment. From validation planning and protocol development through execution, review, and final reports, our teams work within GMP environments to deliver compliant, well-documented qualification packages aligned with current industry standards including ASTM E2500, GAMP 5, and FDA process validation guidance.
What We Do
- Validation Planning & Strategy — VAMPs, validation master plans, and risk-based qualification strategies aligned with ASTM E2500, FDA guidance, and site SOPs
- Quality Risk Management (QRM) — identification, assessment, and mitigation of risks to product quality, patient safety, and data integrity through risk-based validation and qualification approaches.
- Protocol Execution — on-site execution with trained personnel, deviation handling, and real-time documentation
- FAT / SAT — Factory Acceptance Testing and Site Acceptance Testing planning, execution, and documentation
- Computer System Validation (CSV) — user requirements, functional specifications, risk assessments, IQ/OQ/PQ, and 21 CFR Part 11 assessment
- Computer System Assurance (CSA) — risk-based, fit-for-purpose qualification aligned with current FDA CSA guidance
- Equipment Qualification — IQ/OQ/PQ for manufacturing equipment, instruments, utilities, HVAC, and clean room systems
- Validation Remediation & Gap Assessment — documentation review, gap identification, and remediation planning
- Change Control Support — impact assessments, change documentation, and requalification scope definition
- Lifecycle Documentation — periodic reviews, validation maintenance plans, and ongoing qualification support
Why Choose JCA
- Deep Manufacturing Process Knowledge — Hands-on expertise in solid dosage, biopharmaceutical, and medical device manufacturing processes, extending beyond regulatory compliance to equipment, operations, automation, and qualification.
- Risk-Based Approach Aligned with Current Guidance — ASTM E2500, GAMP 5, and FDA CSA principles focus validation effort where it matters most.
- Experienced in Regulated Environments — direct pharmaceutical, biotech, and medical device manufacturing experience in FDA-regulated facilities.
- CSV and Digital System Expertise — validation of MES, SCADA, historians, custom applications, and other computerized systems under 21 CFR Part 11 and GAMP 5.
- Site-Ready Documentation — clear, traceable deliverables aligned with client SOPs, templates, and quality systems.
- On-Site and Remote Support — flexible support for protocol development, review, execution, and project leadership.
- Integrated with Project Teams — qualification activities coordinated with automation, engineering, and IT project schedules.
Relevant Experience
Facility-Wide Environmental Monitoring System
Commissioning and validation of an environmental monitoring system supporting a 740,000 sq. ft. pharmaceutical manufacturing facility, including system integration, SOP development, training, and operational readiness.
Kneat Digital Validation Implementation
End-to-end implementation of Kneat, transitioning paper-based validation processes to digital workflows, including site requirements, SOPs, templates, training, initial validation, hypercare, and on-site administration.
New Packaging Line Commissioning & Qualification
Complete commissioning and qualification of a pharmaceutical packaging line, including facility infrastructure, utilities, packaging equipment, serialization systems, and validation documentation.
Manufacturing Facility Expansion Validation
Comprehensive qualification and validation of a manufacturing expansion and new equipment, including change control, commissioning, IQ/OQ/PQ, SOP development, and validation lifecycle documentation.
Technical Expertise
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