Computer System Validation
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:
- Gap and/or Risk Assessments of the software, infrastructure, and IT services your business relies on, whether on-site or off-site
- Assessment of other quality system elements and supporting processes including staff training, SOPs, document control, corrective and preventative actions, and problem reporting
- Third-party supplier audits to evaluate the capabilities and quality systems of a prospective vendor
- Response audits when there are concerns with the performance of a purchased product
- Computer System Validation summary reports
Kymanox Computer System Validation (CSV) Capabilities
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.
Kymanox SAP ERP
Kymanox Cognitus SAP Alliance
“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.
"I find the Kymanox team to be ambitious, intelligent, and helpful. They are a big asset to us in many areas. For the latest manufacturing environmental monitoring project they worked on, they provided great suggestions on the program, helped us write and execute the qualifications, and helped us work with a third party to support the testing of the qualifications. They did a really good job, stepped up to the plate, and were able to meet commitments we would not have been able to meet without them. They go above and beyond to collaborate with us to ensure the work is done right the first time.”
Kymanox is the premiere one-stop solutions provider supporting commercialization of vital medicines and treatments for people to live better, love longer, and Get More Done.
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