Northstar Validation Solutions
Excellence That Guides. Performance That Delivers
Our Services
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• Equipment IQ/OQ/PQ
• Process validation (PPQ)
• Cleaning validation
• Facilities & utilities qualification
• Validation master planning
• Protocol and report development
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• GxP software validation per GAMP 5
• 21 CFR Part 11 & Data Integrity assessments
• URS, RTM, risk assessments, IQ/OQ testing
• Firmware upgrades & system decommissioning
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• SOP development, revision, harmonization
• Change control management & remediation
• Audit readiness and gap assessments
• CAPA development and documentation cleanup
• QMS alignment with FDA requirements
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• Equipment decommissioning & asset retirement
• EAMS – Enterprise Asset Management System documentation and verification
• Calibration plan development & criticality ranking
• Instrumentation logbook management
• URS, FAT/SAT, and engineering documentation review
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• FMEA & risk assessments (ISO 31000 framework)
• Data integrity risk reviews
• Power BI dashboards for validation, calibration, & risk
• KPI and performance tracking dashboards
• Validation analytics and digital transformation support
About our company
MISSION STATEMENT
Our mission is to provide high-quality validation, documentation, and technical support services that ensure GMP compliance and operational readiness. We strive to be a trusted partner by delivering clear guidance, dependable execution, and solutions that strengthen quality systems and support efficient project delivery.
VISION STATEMENT
Our vision is to become the leading provider of validation and compliance services in the pharmaceutical industry, recognized for exceptional quality, trusted expertise, and unwavering commitment to delivering results that exceed regulatory and operational expectations.
Contact Us
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