Computer Systems Validation

At Quality Resource Solutions, LLC, we understand the critical importance of computer system validation (CSV) for the manufacturers of finished pharmaceuticals and components. Our CSV service provides distinct advantages to our clients by offering in-depth knowledge of 21 CFR Part 11, as well as the regulated process equipment and GMPs of regulatory agencies.

We offer a range of services to meet your specific needs, including training for start-ups new to the regulated industry on validation, Part 11, and data integrity obligations. We also conduct gap analyses of your systems against regulatory requirements (e.g., Part 11) and offer advice on addressing critical priorities.

Our team of experts serves as a “sounding board” for ad hoc compliance questions within your organization, and we develop practical, customized, and appropriate approaches to your CSV efforts and documentation. We also review and revise your vendor qualification SOPs, bridging the gap between IT, business units, QA, and vendors by addressing expectations and responsibilities.

In addition, we offer staff training on CSV concepts and Part 11 regulations as validation projects are launched. We identify and assess risks and compromises to data integrity as your data flows through your systems, writing validation plans and summary reports for your systems.

Our team also identifies system relevance, vendor risk, and interprets audit findings, providing validation document templates to ensure your processes are uncompromisingly efficient and repeatable. Finally, we work with your business units to define and document requirements for new computer systems.

At Quality Resource Solutions, LLC, we are committed to providing our clients with high-quality, reliable, and cost-effective computer system validation services. Contact us today to learn more about how we can help your organization achieve CSV compliance and ensure data integrity.