The Food and Drug Administration (FDA) requires life science companies to have controls on systems utilized to manage electronic data and records. These systems of hardware, software, and IT networking can be very complex and are sometimes not under Quality Assurance (QA) change management. 

The Kymanox Computer System Validation (CSV) Team provides a risk-based  and business process focused approach to testing and validation services, ensuring that each of your systems are in compliance with FDA regulations and guidelines, meaning all systems are secure, recoverable, validated, properly maintained, and that any electronic signatures produced are genuine. The team also offers Standard Operating Procedures (SOPs) to address the IT infrastructure including Data Backup, Data Security, Computer System Validation, and other aspects of computer systems that support electronic records and signatures, as well as Software as a Service (SaaS) hosted platform recommendations for uses in document control or business management, qualification, and development of SaaS infrastructure.

Our CSV deliverables include:

1. Gap and/or Risk Assessments of the software, infrastructure, and IT services your business relies on, whether on-site or off-site
2. Assessment of other quality system elements and supporting processes including staff training, SOPs, document control, corrective and preventative actions, and problem reporting
3. Third-party supplier audits to evaluate the capabilities and quality systems of a prospective vendor
4. Response audits when there are concerns with the performance of a purchased product
5. Computer System Validation summary reports

Kymanox has developed a suite of procedures and templates that provide a foundation for implementing a comprehensive Computer System Validation (CSV) program within a biotechnology, pharmaceutical, or medical device organization.

“GALLOP FOR LIFE SCIENCES - POWERED BY KYMANOX"

Cognitus Consulting, LLC and Kymanox have approved a strategic partnership to streamline FDA compliant SAP S/4 HANA solutions for Life Sciences organizations. Cognitus is primarily responsible for SAP S/4 HANA Expertise, Integration, and Analytics, while Kymanox is primarily responsible for Quality, Validation, and Compliance.