Xybion/Maximo® Partnership for Trusted Life Sciences Asset Management

Xybion’s IBM Maximo Solutions provides industry-specific capabilities to support Life Science and Pharmaceutical manufacturing business requirements. We are industry-recognized specialists in implementing and supporting IBM Maximo deployment in Pharmaceutical manufacturing environments. With expertise in FDA guidelines and regulatory compliance challenges such as 21 CFR part 11 (for support of electronic signatures and electronic audits), calibration of instruments, tools & measurement equipment and standards, support for asset-related CAPA processes as well as extensive computer system validation expertise, our team provides a unique Life Science solution for IBM Maximo.

As industry experts, Xybion brings deep domain proficiency on implementing, managing and maintaining your Maximo solution in a highly-regulated Life Sciences industry. Asset management is often tied to quality, compliance and risk management. Since Xybion offers cross-functional solution for quality & compliance management, preclinical data management and systems validation, we bring a much broader set of skills that are specifically designed to support Life Science companies.

Life Sciences Asset Management Capabilities

  • Audit trail management to meet 21CFR11 guidelines via our CAT™ application for Maximo
  • Process consulting for Maximo use in Life Science settings
  • Integration of Maximo with quality and compliance management applications and processes
  • Maximo application & software validation
  • Templates to speed deployment:
    • Validation Testing
    • Protocols
    • Standard Operating Procedures
    • Specification Documents

Asset Management in Heavily Regulated Drug Development and Manufacturing Process

  • Laboratory Equipment Maintenance Records and Service Management
  • Manufacturing Equipment Validation
  • Computer Systems Validation
  • IT Asset Management
  • Software Quality Assurance Testing
  • Records Management

Our regulatory testing experience has been applied to industries outside of Life Sciences, including the Transportation industry for compliance with the Federal Rail Admiration regulations (FRA).

Our life science industry capabilities extend further as we deliver cutting-edge compliance solutions with our flagship products such as Pristima Suite for R&D, and eQCM for Quality Management.