"They took the time to understand our unique needs and delivered solutions that not only kept us compliant but also improved our operational processes. We couldn’t ask for a better partner!"
- Kishna Celce
"We’ve worked with several companies over the years, but this team stands out for their expertise in both computer system validation and technical writing. Their audits are comprehensive and insightful, helping us improve our internal processes. Thanks to their thorough documentation and support, we’re confident in our compliance and efficiency!"
- Elna Poulard
"Working with this team has transformed our approach to compliance and documentation. Their computer system validation services were thorough, and they handled every step with precision and efficiency. The technical writing they provided was clear and easy to follow, making it simpler for our team to stay on top of regulations. Highly recommended!"
- Alex Gutzmore
Explore Our Services
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Technical Writing
Our technical writing services deliver clear, concise, and accurate documentation that supports your regulatory submissions and internal audits. Our experts can create various technical documents, including validation plans, test scripts, standard operating procedures (SOP), quality policies, work instructions, design documents and guidelines.
Auditing
We specialize in comprehensive auditing and support services to ensure your operations remain compliant, efficient, and effective under industry regulations. Our ISO9001-certified auditors provide expert auditing for computer system validation and conducting third-party audits to empower continuous improvement. We also offer customized training solutions to keep your team knowledgeable and compliant, along with tailored Standard Operating Procedures (SOPs).
For Home and Community-Based Services (HCBS), we develop specialized policies and procedures to align with regulatory requirements. Additionally, our employee record management services help you maintain accurate, compliant, and up-to-date personnel documentation.
Staffing
We provide specialized staffing solutions for validation consulting, quality assurance (QA), quality control (QC), and programming roles. Our team connects you with skilled professionals to meet your business’s technical and compliance needs, ensuring reliable support exactly when you need it.
Interactive Response Technology (IRT) Assistance
Our specialized IRT (Interactive Response Technology) assistance services provide the support you need to manage trial operations smoothly and efficiently. From patient randomization and drug supply management to real-time data capture and seamless system integrations, our IRT experts work with you to ensure precision, compliance, and adaptability at every stage.
The GQI Advantage
Innovative CSA Techniques
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Accelerated Validation: Our innovative CSV techniques streamline the validation process, reducing time-to-production and minimizing disruptions to your operations.
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Risk-Based Approach: We employ a risk-based approach to validation focusing on critical system components and prioritizing validation efforts accordingly.
Expert Guidance and Tailored Solutions
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Deep-rooted Expertise: Our team possesses over 14 years of validation, compliance, and quality assurance, ensuring expert guidance throughout your project.
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Customized Solutions: We work closely with your organization to understand your specific requirements and develop tailored solutions that meet your validation and internal needs.
Comprehensive Support and Ongoing Maintenance
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End-to-End Support: From initial planning and implementation to ongoing maintenance, we provide comprehensive support throughout the entire project lifecycle.
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Robust Documentation: We deliver detailed and accurate documentation to support your regulatory submissions and internal audits.
Let Us Elevate Your Quality Standards
We specialize in Computer Software Assurance (CSA), Compliance, Quality Assurance, Auditing, and Professional development, with a strong focus on Electronic Quality Management Systems (eQMS) like Veeva Vault and MasterControl. Our knowledgeable and driven team leverages cutting-edge techniques to achieve your goals more efficiently and effectively. Whether you're in healthcare, non-profit or the life science industries, our commitment to excellence ensures you stay compliant, meet project deadlines, and solve complex problems with precision. Partner with us to drive innovation and quality in your organization.
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See How GQI Can Help Accelerate Your Goals
Tired of navigating complex regulations and inefficient processes? Global Quality Improvement offers innovative solutions to streamline your operations and accelerate your goals.
Picture your company thriving with fully validated systems, secure data, and an empowered team. With GQI as your partner, this vision is achievable. Schedule a consultation today and discover how our expert guidance can transform your business.
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Regulations & Guidelines
21 CFR Part 11
Part 11 has been established by the Food and Drug Administration (FDA), it outlines the criteria for ensuring the trustworthiness, reliability, and security of electronic records and signatures, essentially stating that digital records and signatures can be considered equivalent to paper records and handwritten signatures if specific requirements are met, including robust access controls, audit trails, and proper user identification to protect the integrity of data within regulated industries like pharmaceuticals and medical devices.
