Infrastructure Qualification Status Assessment


Overview


While undertaking a technological overhaul of a process system, a pharmaceutical company identified the necessity to conduct a qualification status check on its IT infrastructure. Given the lapse in such activities over the years, the department head nourishes doubts regarding the consistency of the documentation. Consequently, our team was enlisted to execute what initially appeared to be a straightforward evaluation of the IT equipment. 


The primary challenge stemmed from time constraints: with imminent and scheduled production downtime, MAASI was tasked with completing the entire process within a mere three months.


Initially, the internal IT team regarded the interviews and specific inquiries into processes and configurations as disruptive to their daily routines. This sentiment was not solely due to the department's unpreparedness for a detailed technical analysis, but also because of unclear responsibility management grounded in habitual practices and conventions, which hindered employee engagement with quality matters.


Solution


The analysis team initiated contact with key stakeholders, outlined the action plan, and conducted preliminary interviews. They then gathered documentation from both global and site layers, assessing discrepancies in methodology and approach, and mapping areas of overlap and contrast. Despite fewer interviews than anticipated, the team prioritised evaluating the systems and processes portfolio.


Following this, MAASI presented the initial findings, emphasising key discoveries and pressing issues. Their primary goal was to minimise disruption to concurrent projects while ensuring ongoing communication with stakeholders.


At the conclusion of the results analysis phase, the team presented a comprehensive report detailing technical and practical implications, along with a matrix of findings and urgent priorities. All information was visually correlated, and three distinct qualification approaches were proposed, informed by a proprietary methodology focused on sustainability, implementation timelines, and flexibility.


Using a constructive and positive approach, combined with critical thinking, the team successfully combined the MAASI methodology with client requirements, generating various resolution scenarios based on factors such as:


  • Costs associated with individual findings;
  • Interdependence and cascading effects of individual resolution actions;
  • Time required for implementing resolution actions;
  • Time needed to acquire skills and solutions.


As a result, the client was empowered to determine the preferred approach, allowing for the containment of unforeseen efforts compared to the initial project and the spreading of costs over the desired timeframe.



Achievement

Tailored Training

Thanks to focused training based on the findings, the IT team has gained a deeper insight into internal workflows and those of client departments. Consequently, the IT department has acknowledged the necessity of segregating internal functions for more efficient delivery.


Internal Service Restructuring

The shift in perspective resulting from the analysis has prompted the IT department to recognise the importance of aligning its service offerings with business needs. Furthermore, it has underscored the significance of strategic service management through the Service Portfolio.

IT Infrastructure Enhancement

Through corrective measures, previously unaddressed service lines have been developed. The implementation of the remediation plan has allowed the client to reshape a crucial aspect of the organisational framework.

Quality Assurance Restoration

The department has come to appreciate the value of the PDCA cycle, risk management, and the importance of clearly defined workflows and responsibilities.


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Support for establishing Governance for ICS/OT and utilising OT Infrastructure Services