Quality and Compliance

A solution-based approach to solving problems

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 with the challenges in healthcare, devices, and research industries to blend our expertise with business acumen to provide innovative and compliant solutions for various maturity levels of your organization.

Our Consulting Services Simplify Processes and Drive Sustainable Growth

Regulatory experience matters

Our team has over 200+ years of cumulative industry experience and has subject matter expertise in a dynamic, regulated, and fast-growing Life Sciences industry environment. We understand the complex, ever-changing regulatory environment and markets with the challenges in the healthcare, devices, and research industries. We blend our expertise with business acumen to provide innovative and customized solutions for the various maturity levels of organizations.  

Auditing (CSV, 21 CFR Part 11, Data Integrity, and Supplier)

We perform CSV-related supplier audits to help assist with evaluations & vendor selection. In addition, we can help improve compliance by performing CSV audits of in-house systems and executing gap assessment reports and remediation planning to help minimize compliance risk to your systems. Xybion also carries out 21 CFR Part 11 Assessment walk throughs and can help identify potential risks to data integrity and other compliance regulations.

CSV Methodology Design, Implementation , and Enhancements

Experts that bring robust experience with 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 have 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 of traditional computer systems validation to a more efficient computer systems assurance methodology.

Project Quality Management Design and Implementation

We provide quality solutions to design and implement compliance within your project management methodology, thereby reducing rework cost, time, and effort. We’ll perform assessments of the current methodology, and introduce robust quality checks, key performance indicators, and process controls to ensure a defined gating system. Additionally, we implement dashboards, lessons learned, and realization at the overall program level for conducting project quality management.

Regulatory Compliance

Our seasoned experts can roadmap and strategize a phased appropriate Quality Management System (QMS) design by performing gap analysis, reports, and master remediation planning tailored to your organization and product lifecycle. We can develop quality manuals or policies and support SOPs or WIs and forms to support handling quality events (deviations, non-conformances, investigations, CAPAs, complaints, and training program design or execution for your site or staff). Additionally, we can support you with inspection and regulatory audit preparation activities and organizational change management.

Xybion XDP Preconfigured Apps

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