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About QSR Compliance

QSR Compliance is a regulatory compliance leader specializing in all facets under the 21 CFR Part 11 and 820 regulations. Our strategic approach has assisted over 250 clients reduce compliance costs through managing business risk with applicable FDA and international regulations. QSR has warranted solutions for managing global compliance across the end-to-end supply chain. The 820 QSR can be a difficult regulation to understand. QSR's validation methodology for equipment and software applications can accelerate your project schedule and will help maintain a validated state through developing change control processes that creates visibility for all stakeholders/operators. Our end-to-end validation package includes: ~Risk Analysis ~Validation Planning ~User Requirements and Functional Specifications ~Data Verification ~IQ, OQ, & PQ protocols ~Traceability Matrix ~Validation Reporting Other offerings include: ~Internal Auditing ~Documentation Controls ~Design Controls ~CAPA Management The QSR Compliance team values your business/quality objectives, and are here to help you drive your project costs down through leveraging our library of validation scripts and process controls. Contact us today for a free consultation - info@qsrcompliance.com

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