Our Services

Governance & Compliance Services

Governance & Compliance Fact Sheet view pdf

At Maxiom Group, validation and testing are an integral part of our IT Solutions implementation methodology. In the life sciences industry, an IT Solution is not properly implemented until adequate controls to maintain the system in a validated state have been established. Maxiom Group provides clients with expertise and guidance in the design and development of the operational policies and procedures required to assure management, users and regulators that their IT systems are operating, and will continue to operate, as intended.

Maxiom Group closely follows Good Automated Manufacturing Practices (GAMP 4) and standards for helping clients incorporate a solid risk-based approach to IT Governance, SDLC and Validation in their IT organization. Working with Maxiom Group puts our clients squarely down the road to IT compliance.

Maxiom Group provides expertise in the area of:

  • IT Governance
  • Risk Management
  • Software Development Lifecycle
  • Master Validation Planning
  • Computer System Validation Planning
  • Validation Execution (IQ, OQ and PQ)
  • Standard Operating Procedures

A commercial biotechnology company had recently started implementation of a new enterprise resource planning (ERP) system. Working with technical consultants from the software vendor and a separate firm to handle system validation was becoming increasingly difficult, time-consuming and costly.

Maxiom Group was engaged to perform subsequent phases of the ERP implementation with an approach that more tightly integrated the validation activities within the implementation process.

Among our activities were:

  • Developing validation requirements for the ERP system
  • Documenting pre- and post-implementation business processes
  • Developing, enhancing and executing test scripts
  • Documenting test results

As a result, validation was addressed as an integral part of the ERP implementation which then proceeded more smoothly, at an accelerated pace and with a lower total cost.