We customize our Computer System Validation services to handle your needs.
We can deliver a project, augment your staff, manage services onsite, or manage them through our onshore or offshore capacities.
Computerized systems can include the following: control systems, automated manufacturing equipment, laboratory data capture systems, automated laboratory equipment, computers running the laboratory, manufacturing execution systems, manufacturing or clinical database systems, and any interfaces to other Gx P systems.
If one or more of these systems runs your operations, SQA Solution offers a complete range of services for your computer validation needs.
Our Computer System Validation Team provides value by bringing a strategic balance of industry experience, technical skills, and best practices to the engagement.
We succeed by integrating our expert services with your company culture and procedures.
Furthermore, we support your quality, compliance, and operational goals on engagements with the following activities: requirements definition and traceability, risk assessment and risk mitigation, validation planning, internal and external vendor audits, SOP development, test script and test plan development and execution, validation summarization, deployment, and continuing validation maintenance.
Our SQA Solution Computer System Validation team can work with your company in testing and validation, regulatory compliance, and audits.
SQA Solution understands the necessity for validating regulated systems in a cost-effective manner, doing so correctly, and complying with specified rules and regulations.In the life science industry, software and systems that perform Gx P related functions need to be verified.Our testing and validation includes Gx P, PDMA, 21 CFR Part 11, Sarbanes-Oxley (SOX), and so on.Our expert team has all the necessary training in FDA regulations, other industry regulations, and best practices, such as risk-based methodologies.
If your company is regulated by the FDA or other agencies, we offer a complete range of testing and validation services within the life sciences arena.This encompasses computer systems validation (CSV), testing of non-regulated and regulated equipment, systems, facilities qualification, and regulatory compliance.