Provide innovative and compliant solutions for various maturity levels of your organization
Our experts bring cumulative industry experience and have subject matter expertise in the dynamic, regulated, and fast-growing life sciences industry environment. We understand the complex, ever-changing regulatory environment and markets, along with the challenges in healthcare, devices, and research industries. We blend our expertise with business acumen to provide innovative and compliant solutions for various maturity levels of your organization.
We perform CSV-related supplier audits to assist with evaluations and vendor selection. Additionally, we can help improve compliance by performing CSV audits of in-house systems and executing gap assessment reports and remediation planning to minimize compliance risk to your systems. Xybion also carries out 21CFR Part 11 assessment walk-throughs and can help identify potential risks to data integrity and other compliance regulations.
Experts who bring robust experience in implementing proven computer systems validation lifecycle methodologies that have been used to meet industry best practices and satisfy FDA and EU regulatory compliance. We have generated and implemented CSV policies, SOPs/WIs, and conducted training for site/staff. We can adapt to any SDLC lifecycle, whether waterfall, agile, or hybrid approaches, in addition to assisting with the transition from traditional computer systems validation to a more efficient computer systems assurance methodology.
Our experts work closely with your business, QA, and IT teams, as well as software suppliers, to ensure that a pragmatic and risk-based strategy is implemented in line with user and regulatory requirements, the resources available, and any associated risks with the system implementation.
Our automated validation testing solutions enable real-time capturing of validation artifacts/deliverables, easing tracking, traceability, and status. This will allow control and maintenance of your validation lifecycle phases, from concept, project, operations, and retirement.
Xybion professionals possess expertise in technology, data, transformation, and process change. We collaborate to create and execute a custom digital strategy that aligns with your business model.
Our experienced experts bring subject matter expertise and cumulative industry experience in the dynamic, regulated, and fast-growing life sciences sector.