Transforming Quality in the Cloud – An Axendia Executive Insight Brief

Whitepaper | January, 2022

The phrase digital transformation has many meanings depending on the size and maturity of an organization, as well as who you ask.

We can easily break down this phrase into two parts:

Digital – moving from manual, paper-based systems to data/digital evidence/platforms

Transformation – cultural change to drive streamlined, optimized and resilient processes

The impact of the global pandemic was felt across industries. Overnight, supply chains broke apart and employees were told to stay home and work remotely. In the case of Canon Medical Systems UK, where 20% of the workforce was already working remotely, the remaining office personnel who would typically be onsite were able to connect remotely to Salesforce and QMS. When it comes to digital transformation at his organization, Dik Hoogmoed, Director of Regulatory Affairs & Quality Assurance at Canon Medical Systems, UK, pointed out, “If anything, it probably sped it up.”

It was same in the case of Mustang Bio. Edward Armstrong, Director of Quality Assurance at Mustang Bio said, “For my organization, digital transformation means we are no longer generating more paper. GMP stands for good manufacturing practices, but in Life-Sciences, GMP should mean ‘Generate More Paper.’ Digital transformation gives us more real-time data and information related to our patients. We produce autologous products. Data is everything. Knowledge of where that product is in the lifecycle of manufacturing is critical. We have a gene therapy that is three days to manufacture, 20 days of release-to-process. Knowing where we are – that’s critical.”

Axendia’s research proves that Life Sciences companies have the ability to leapfrog from paper-binders to digital sustainability. While the majority of companies are still relying on stand-alone solutions, digital transformation is being approached using modern cloud technologies.

Axendia sheds light through this whitepaper on how Salesforce-based ComplianceQuest solution suites are helping Life Sciences companies like Canon Medical Systems and Mustang Bio in their journey towards digital transformation.

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