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Coordinating software validation for four new pharma systems

Software Validation




Business situation


A world-class pharmaceutical company reached out to Ergonomics Factory for guidance on software validation within a larger global IT project aiming to harmonize business processes and the IT landscape in the context of release execution. Having collaborated on previous development and validation projects with one of our software validation experts, the client’s project management team was confident in our ability to coordinate an upcoming software validation project with a high level of complexity.




The Challenge


The client needed to synchronize software validation for the release of four interfaced systems, including their in-house developed:

  • Drug product and drug substance specification system

  • Certificates for release system

  • Release control system

  • Delivery check system

This high-priority work would need to be completed in a short span of six months. In addition, their safety- and product-release-critical systems needed parallel validation to stay on track with the timing of the company’s global release plan.




The Solution


We created a validation plan, updated the system and functional risk assessments, reviewed system requirements and functional specification documentation, and created a test plan. In addition, Ergonomics Factory supported the testing team by reviewing test specifications and executed tests. Finally, we created a traceability matrix and prepared a final report, including the validation registry.


"Getting ready for our global release was a huge coordinated effort between our business and IT teams. Having expert validation guidance and support from Ergonomics Factory was vital to reaching a point where we could accurately and consistently produce results necessary to meet guidelines for compliance and quality management."


Pierluigi, IT Product Manager



Outcomes


Based on our years of experience with similar projects for pharmaceutical teams, we quickly assessed the criticality of defects found and assessed which ones required urgent solutions before the release. Our familiarity with the client’s internal guidelines and regulations also helped expedite the entire process and enabled us to work in close alignment with both business and IT stakeholders.


Our previous experience and the overall synergy with business and IT teams led to:

  • Accurate, consistent, complete data

  • Production and distribution with higher-than-ever quality standards

  • On-time and on-budget deployment



Benefits


  • Critical defects discovered and resolved

  • Reduced compliance risk

  • Scalable, continuous improvement

  • Maximized efficiency in production and inventory management

  • On-time validation



Updates


The client continues to work on additional improvements and developments to these four systems, within existing and new global projects. In addition, they plan to collaborate with Ergonomics Factory on future projects.





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