HOW WE CAN HELP YOUR COMPANY
Solutions designed to improve your drug Quality Assurance development, strategy and operations
As a premier consulting firm for pharmaceutical companies and medical device companies, Quality Assurance GxP Consulting specializes in providing expert guidance on GxP compliance. Our goal is to help you achieve regulatory compliance and maintain quality in all aspects of your specific products. We customize our services to meet the specific needs of each client, ensuring the best possible results.
Our QA process will help your company make sure you have the tools and quality systems to
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Manage Risk - asses severity, document and mitigate risk of product failure
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SOP - publish and regularly review your GxP standard operating procedures
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Controls - the processes to ensure and achieve the required standards for your product
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Documentation - Evidence that these processes and tasks have been performed
Auditing
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Internal audit design and support
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External audit performance & follow through
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Follow-up auditing
Quality Systems Management including:
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CAPA, Change Control, Deviation Management
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Risk Based Validation
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Document Management
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Recommending appropriate quality software systems
Quality Assurance including:
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Project Management
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Quality Systems Development
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Quality Culture
Requirements including:
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Good Manufacturing Practice (GMP)
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Medical Devices & Biotechnology Regulations
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ISO Business Standards
