“Exigence equals professionalism and capability. The team is highly skilled and delivers in a timely and calm manner, with patience and with a smile. Very highly recommended to any firm seeking a team of professionals who are extremely flexible and across all aspects of IT.” – Julie Meldrum, Global Corporate Communications, Mesoblast
Mesoblast is an innovative biotechnology company with an emphasis on regenerative medicine.
Mesoblast required a new electronic regulatory submission system which complied with ICH, 21 CFR Part 11 and other international guidelines for FDA submissions.
In close consultation with the software vendor, Exigence designed and implemented a fully compliant and highly available infrastructure to support this system. The infrastructure was qualified and validated in line with FDA requirements and now serves as a core platform for the regulatory submission system.
Exigence ensured that the system selected by Mesoblast not only offered the required functionality, but could also operate within the constraints of the existing IT infrastructure, is secure and offered a support/upgrade path for the future.
Successful delivery of this project required collaboration between Mesoblast's regulatory submissions team, the software vendor and their deployment team, as well as Exigence’s IT delivery team.
The key challenges were not only technical in nature, but also to ensure that all teams were on the same page at all times. Aligning user requirements with software functional specifications and delivering a complete system that ticked all the boxes were the primary challenges. Qualifying and validating the entire infrastructure in line with FDA requirements also presented a number of challenges.
“Exigence equals professionalism and capability." – Julie Meldrum
Exigence partnered with a number of vendors to commission the system. The system was one of the leading names in the field of Regulatory Information Management (RIM) with an extensive suite of software that met all of the client requirements.
Exigence chose suitable vendors for the hardware and operating system that would provide the foundations for the software platform. Vendors with a proven track record of quality and reliability were selected.
The system was hosted at an enterprise grade (Tier 4) international data centre with a guaranteed uptime of almost 100%. The network topology allows for high-speed access from all of Mesoblast's international offices.
System virtualisation technology with appropriate backup and disaster recovery ensure high availability.
Exigence was instrumental in delivering an IT infrastructure for a complex regulatory submission system within the allocated time frame and on budget. The infrastructure was successfully qualified, validated and documented. The completion of this project not only fulfils Mesoblast's requirements but allows their geographically disparate clinical/regulatory teams to collaborate more effectively.
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