FDA Computer System Validation
SQA Solution provides quality computer systems validation, 21 CFR Part 11 solutions and compliance consulting services to the pharmaceutical, biotechnology, and medical device industries. SQA Solution focuses on providing cost effective, practical validation solutions to companies operating within an FDA regulated environment. Our professional staff has experience with manufacturing, laboratory, and clinical applications as well as back office and support systems. SQA Solution offers customized solutions for the implementation of automated testing and test management tools by working with each customer to satisfy the requirements of their specific validation process.
Our Computer System Validation solutions include:
- Turnkey validation projects: plans, requirements, design and development, RTM, IQ, OQ, PQ, testing, validation reports
- Outsourcing Services: short and long-term support.
- 21 CFR Part 11 related services: Assessments and remediation
Our testing and validation services will include both testing of new systems as well as integration testing. SQA Solution works with each organization to determine what applications are critical for validation and identifying automation candidates that will produce the largest return on investment (ROI) for the customer. SQA Solution professionals have a wide range of CSV-related system experience, including:
- General services: 21 CFR Part 11 Assessment/Remediation, Gap Analysis, Quality Systems Audits, SOP Development, Customized training, and Automated testing services
- Business Systems: ERP, Electronic Data Management, and Document Management
SQA Solution also provides a wide range of technology to accelerate validation according to the customer's applications and specific needs. For more information on our services, please contact a SQA Solution representative.
Case Study:
SQA Solution has staffed a project for a world biggest imaging company working with top 10 Pharma companies delivering the image analysis for their clinical trials. Our experts were involved in designing and implementing Full Testing Life Cycle; Developed complex SOPs for both SQA and Release Management. Furthermore, we have developed a number of validated test documents such as: Test Plans, Test Cases, Test Reports, Requirements Traceability Matrixes etc... Our work has passed both sponsor audits as well as FDA regulatory audits. Our experts delivered test cases and test scripts to ensure 21 CFR Part 11 validation as well as integration with E-Signature. We have worked with a number of industry wide used tools such as: PharmaReady, gRemedy, Alcea CAPA. Our team has an expertise in the following Therapeutic Areas: Oncology, Neurology, Arthritis, Osteoporosis and Orthopedics.