Infrastructure Qualification for Life Science

Infrastructure Qualification Project for a Diagnostic Image Processing Company.


Infrastructure Qualification Project for a Diagnostic Image Processing Company.

The IT department, known for its efficiency and technical expertise, faced the challenge of infrastructure qualification for the first time, fearing a loss of flexibility due to increased bureaucratisation. Considering their unique structural and functional aspects, as well as their processes, MAASI guided the qualification effort with a strategic mid-term plan. This plan clearly defined the terms, application boundaries, and compensatory measures necessary for the transition to a qualified infrastructure.

MAASI's involvement extended beyond IT infrastructure qualification. The project also prompted a comprehensive reassessment of the organisational structure and processes, both supportive and enabling. By broadening its initial scope, the team provided a structural advantage to the entire company, beginning with the rationalisation of the IT infrastructure. This holistic approach resulted in enhanced efficiency and integration across the organisation.


Following a thorough analysis of the client's IT infrastructure, including process verification, personnel interviews, and review of departmental procedures, the MAASI team addressed the complex network of interconnected findings. They constructed a remediation plan considering the intersection of time, cost, implementation difficulties, and dependencies (both on other remedies and gaps).

The team recommended appropriate remediation and mitigation actions, focusing on work methodologies, clarity of workflows, accountability, and the service model. They then guided the implementation phase through extensive coaching of internal staff.

By applying the MAASI qualification methodology, the team efficiently delivered a fully functional IT infrastructure that complied precisely with regulatory requirements and guidelines.

Furthermore, MAASI supported the training of IT personnel to minimise future infrastructure gaps and enhance the company's operational efficiency.


The qualification work conducted by MAASI Enterprises comprised:

Robust infrastructure qualification

Adhering to the principle of building blocks and viewing infrastructure as a stack of services provided to the company, MAASI's qualification methodology has made the IT department more agile and service-oriented, abandoning outdated constraints with hardware equipment and detailed layouts.

Guided resolution of findings

Through thorough analysis of the IT infrastructure, the client received comprehensive support for addressing Corrective and Preventive Actions (CAPA) and observations.

Qualification of the IT infrastructure

All qualification activities undertaken ensured alignment of the infrastructure with regulatory requirements, enabling confident operation within the industry.

Consulting and training

The IT function underwent extensive training on structuring, task allocation, and enhancing efficiency and effectiveness not only of the IT infrastructure but also of the entire framework of people and processes constituting the realm of information science.


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