Core Services
Equipment Qualification
21 CFR Part 11 assessments, computer system validation lifecycle, IQ/OQ/PQ for production equipment, and vendor audits.
Practice Overview
QRC qualifies production equipment and computerized systems in accordance with 21 CFR Part 11, GAMP 5, and ICH guidance. We run lifecycle CSV from validation planning through periodic review, IQ/OQ/PQ on production assets, and vendor audits that hold up under regulatory scrutiny.
Capabilities
- 21 CFR Part 11 assessment and remediation
- Computer system validation planning and execution
- Production equipment IQ/OQ/PQ
- Vendor audits and qualification
- Periodic review and revalidation
- Maintenance and validation SOPs (backup, security, disaster recovery)
Resources We Provide
- Equipment qualification engineers
- CSV specialists (GAMP 5)
- 21 CFR Part 11 assessors
- Vendor audit specialists
- Periodic review and revalidation resources
Delivery Capabilities
- Validation plans
- Qualification protocols and reports
- Traceability matrices
- Vendor audit reports
- Validation summary reports
Engagement Models
- Dedicated validation and quality resources
- Project-based delivery teams
- Short-term specialists for critical initiatives
- Long-term staff augmentation
- Turnkey validation program teams
- Inspection-readiness and remediation squads
Core ServicesIndustries & Applications
This service is delivered to clients across pharmaceutical, medical device, biotechnology, and regulated manufacturing operations.
PharmaceuticalMedical DeviceBiotechnologyRegulated Manufacturing
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