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Quality and Compliance

Provide innovative and compliant solutions for various maturity levels of your organization

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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.

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

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.

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CSV Methodology Design, Implementation & Enhancements

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.

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Validation-as-a-Service

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.

  • End-to-End Computer System Validation
    Offered for any GxP-related computer system implementation, development, upgrade, and rollout project. Expertise with cloud-based, COTS/configurable, enterprise, standalone, or bespoke-built systems. Services include validation strategy/planning, risk control, requirements elicitation, qualification protocol/execution (IQ/OQ/PQ), deviation handling, traceability, and reporting.
  • Validation Testing Services
    Validation Testing Services is an independent service where Xybion provides functional resources with the relevant system and CSV expertise to execute validation testing of a particular GxP system. We adhere to good testing and documentation best practices and can train in any QMS and/or CSV process. Validation Testing Services can be offered and also executed 100% offshore. We also provide a tool that supports automated validation testing to increase testing/reporting efficiency and control of deliverables.
  • Equipment/Instrument & Process Qualification
    Commissioning & Qualification Modelling is based on GEP, ISPE, and industry best practices for facilities, utilities, and processes to reduce risk to product quality and safety, while increasing efficiency, lowering costs, and saving time. We provide expertise with C&Q master planning, DQs, supplier assessments, process quality risk assessments, user/functional, FAT/SAT, and traditional IQ/OQ & PPQ deliverables.
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Automated Testing 

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.

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Our experts will help provide value-driven capabilities that are ready for adoption to increase productivity, reduce costs, and plan future business strategies that aim to meet company long-term goals.

Strategy & Planning

Xybion's consulting services drive growth, innovation, and resilience through industry expertise and technology-driven strategies.

Operations

Xybion's operational services provide efficient support staff, enhancing productivity and customer service for your organization.

Quality & Compliance

Xybion's industry experts provide innovative and compliant solutions for the life sciences industry, addressing regulatory challenges and healthcare complexities.

Related Services

Strategy & Planning

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.

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Operations

Our experienced experts bring subject matter expertise and cumulative industry experience in the dynamic, regulated, and fast-growing life sciences sector.

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Headquarters

105 College Road East
Princeton, New Jersey 08540

Phone

+1-609-512-5790

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Investors

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© Copyright 2023 Xybion Digital Inc.
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