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 the user and regulatory requirements, the resources available, and any associated risks system implementation.
Xybion has over 25+ years of experience in validation execution with over 500+ successful engagements. We know how the execution of validation testing represents a significant part of overall effort and costs. Xybion’s CSV experts are seasoned with numerous GxP implementations in the Life Science industry. Our experts have demonstrated leadership to take the initiative and have been successful with all aspects of validating and implementing computerized systems.
Offered for any GxP-related computer system implementation, development, upgrade, and rollout project. Expertise with cloud-based, COTs/configurable, enterprise, standalone, or bespoke build systems. Services include validation strategy/planning, risk control, requirements elicitation, qualification protocol and execution (IQ/OQ/PQ), deviation handling, traceability, and reporting.
We provide 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 or CSV. We also provide automated validation testing to increase testing, reporting efficiency, and control of deliverables.
Commissioning and qualification modeling is based on GEP, ISPE, and industry best practices for facilities, utilities, and processes to reduce risk to the product, quality, and safety all while increasing efficiency, lowering costs and time. We provide expertise with C&Q master planning, DQs, supplier assessments, process quality risk assessments, the user or functional, FAT/SAT, and traditional IQ/OQ and PPQ deliverables.
Our automated validation testing solutions enable real-time capturing of validation artifacts or deliverables, easing the tracking, traceability, and status. Control and maintain your validation lifecycle phases from concept, project, operations, and retirement.