Computer System Validation
Our SQA Solution Life Sciences team can work with your company in testing and validation, regulatory compliance, and audits. We service leading pharmaceutical, biotech, and medical device companies.
We customize our consulting engagements to handle your needs, whether it’s delivering a project, augmenting your own staff, managing services onsite, or managing them through our onshore or offshore capacities.
Our CSV 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.
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 performs GxP related functions need to be verified. 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 GxP systems. If one or more of these systems runs your operations, SQA Solution offers a complete range of services for your computer validation needs.
Testing and Validation Services
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. Our testing and validation includes GxP, 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.
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.
Depending on your needs, we can take on a leadership role and manage the entire validation project following our quality program with scheduled deliverables and staffed with our consultants or, alternatively, we can provide consultants to join your team at your site who will adhere to your own quality program.
SQA Solution’s Validation Services
Our computerized systems and software validation services include the following:
- Building Management Systems (BMS)
- Process Control Systems (PCS)
- Laboratory Instrument Software
- Laboratory Information Management System (LIMS)
- Enterprise Resource Planning (ERP)
- Electronic Document Management Systems (EDMS)
- Corrective and Preventive Action Systems (CAPA)
Value-Added Validation
Validating Computerized Systems makes sure that an automated system is suitable for its designed use. Too many validation endeavors lead to tons of documentation without satisfying the goal of validation. SQA Solution’s validation methodology makes sure that customized and configured portions of the application are diligently validated. The end result will be a well-functioning program that is sure to please any inspector.
TrackWise Validation
SQA Solution specializes in efficient, cost-effective TrackWise validation.
21 CFR Part 11
21 CFR Part 11 is complicated and non-negotiable. At SQA Solution, we have the knowledge and expertise to help your organization in its effort to develop a well-established plan and to proceed to implement and validate this plan to bring your company into compliance with this law.
Regulatory Compliance Services
SQA Solution has years of experience providing regulatory compliance services. These include performing audits, qualifications, validation, and managing documentation.
Our previous CSV engagements have included:
- Quality Assurance review and analysis of project documentation deliverables.
- Regulatory Compliance and Risk Assessments, including for GLP, GCP, GMP, SOX, 21 CFR Part 11, and PDMA.
- Independent internal and external vendor audits, both GxP and IT.
- Development of Standardized Regulatory Practices and Processes.
