Navigating a Highly Regulated GxP Environment:

• Novo Nordisk’s cloud infrastructure service operates within a stringent regulatory framework, adhering to GxP standards. Compliance with GxP involves detailed documentation, rigorous testing, and quality assurance processes to ensure patient safety and product reliability.
• Poly Consulting faced the challenge of maintaining high development speeds without compromising on regulatory requirements. Every change to the infrastructure needed to align with GxP standards, requiring meticulous planning, execution, and documentation. Achieving this balance between speed and compliance was critical for ensuring project success.

Complex and Inefficient Technical Architecture:

• The existing cloud infrastructure featured a highly complex architecture, contributing to prolonged build times and limiting operational efficiency. This complicated system required extensive expertise to fully understand, optimize, and streamline without disrupting daily operations.
• Long build times (up to 1.5 hours) created delays in development cycles, affecting productivity and stakeholder satisfaction. Poly’s team needed to simplify this intricate architecture to make it more maintainable and scalable, while also reducing build times significantly—a challenging task in a regulated environment.

Effective Stakeholder Engagement and Requirement Translation:

• Poly Consulting’s team needed to communicate effectively with line-of-business customers, gathering insights and translating these into actionable technical requirements. This required a deep understanding of both the technical architecture and the business context to ensure the final solution met the expectations of all stakeholders.

Rapid Talent Onboarding and Value Delivery:

• The project required specialized expertise in cloud infrastructure, regulatory compliance, and GxP standards. Poly Consulting faced the challenge of quickly sourcing and onboarding professionals with the right skill set to fit Novo Nordisk’s highly regulated environment.
• Novo Nordisk needed a partner who could deliver results immediately while respecting budgetary constraints. Poly Consulting had to ensure that the team was fully operational from day one, delivering measurable value and addressing project requirements without delay.

Balancing Scalability and Maintainability with High-Speed Delivery:

• Novo Nordisk’s cloud infrastructure needed to be stable and scalable, supporting future growth while remaining easy to maintain. However, building a scalable solution while simultaneously reducing build times and simplifying architecture required careful balancing.
• Poly Consulting needed to optimize the infrastructure for current performance demands while ensuring flexibility for future expansions. This included implementing improvements that would not only reduce build times but also support long-term maintainability without increasing complexity.