Empowering Businesses with Strategic Technology Solutions
Empowering your digital transformation with expert IT services.
Empowering Businesses with Strategic Technology Solutions
Empowering your digital transformation with expert IT services.
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Empowering your digital transformation with expert IT services.
Empowering your digital transformation with expert IT services.
Welcome to CSA-QMS LLC! We specialize in providing training and consulting services for Computer Service Validation/Assurance and Software Quality Management Systems as per regulatory requirements. As pioneers in Validation services in the US, we offer a wide range of services to major Pharmaceutical, Biotechnology, and Medical Device companies globally. At CSA-QMS Validation, we are well-equipped to handle any challenge and help you achieve success. Our services are compliant with all applicable regulations, and we have a proven track record of delivering excellent results for our clients. If you're looking for expert Validation and Verification services that align with regulatory requirements, CSA-QMS LLC is the right place for you! Validation & Verification
We specialize in guiding consultants towards their dream careers in the medical device and pharmaceutical sectors by thoroughly understanding their unique needs and matching them with suitable job opportunities. Our mission is to empower candidates from diverse backgrounds, ensuring they have the support and resources necessary to excel in the testing and quality assurance of quality systems. Through personalized assistance and a commitment to inclusivity, we strive to create a pathway for success in these vital industries.
Our services aim to enhance your operational execution, reduce your organization’s risk, and boost overall productivity. As your partner in life sciences, our engineering, technical, and consulting services cover all aspects of operations.
Computer Systems Validation, abbreviated as CSV, is a “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.” Our risk-based approach to validation focuses on the appropriate amount of testing and the number of deliverables, while remaining compliant with applicable standards and regulations. Validation & Verification, Testing & QA, Computer Systems Validation abbreviated as CSV is a “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled”. Our is risk-based approach of validation focuses on the right amount of testing and number of deliverables, while still in compliance with applicable standards and regulations. Validation & Verification, Testing & Q
Regulated industries, such as medical devices and pharmaceutical manufacturing, must establish and follow many compliance procedures to ensure their final product is safe for distribution or sales. Our industry expert team can help in various areas, including, establishing robust QMS based on customer needs, performing GAP analysis, taking remediation actions, and performing periodic reviews. Validation & Verification Testing & QA quality systems
We specialize in IT staffing, leveraging our extensive industry knowledge to help organizations build high-performing teams. We provide access to highly skilled professionals in fields such as Software Validation, Equipment Validation, BAS, Commissioning, and more. Whether you require contract-based specialists, full-time hires, or project-based teams, we ensure you receive the right talent to fuel your success.
Technical writing consultants recognize that comprehensive documentation is vital at every phase of pharmaceutical and medical device development and production. Therefore, our consultants strictly follow Good Documentation Practices (GDP), which are essential for ensuring compliance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards.