Case Study

AstraZeneca modernise their regulatory submission process with CARA

Learn how a multinational pharmaceutical and biopharmaceutical company standardised their processes.

“Senior leaders from across the AZ business were genuinely taken by surprise by the extent of the positive reaction to CARA, commenting that they had never before seen such a turnaround in user sentiment from a system improvement initiative, nor one accomplished so seamlessly and smoothly.”

Ashley Birch, Global Head, Information Strategy Systems & Analytics, GRAPSQA

lregulatory

Regulatory Submission

lquality
lsafety
lclinical
lenterprise

Statistics

10,000 users

100+ countries

8 million documents

GxP records
21 CFR Part 11

AstraZeneca – at a Glance

AstraZeneca plc is a British–Swedish multinational pharmaceutical and biopharmaceutical company with its headquarters in Cambridge, England. AstraZeneca has a portfolio of products for major disease areas including cancer, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation.

The Problem

AstraZeneca was using a legacy system to manage regulatory submission documents. This system did not provide easy navigation, and especially did not have good functionality to create “complex document structures” like regulatory submissions. The system also did not perform well for the large number of users at multiple locations worldwide.

The Solution

CARA was selected as the replacement system, and implemented in a fast timeline. The implementation was considered very successful by AstraZeneca, winning an Innovation Prize internally (these are normally only awarded to new products / compounds / scientific research). The senior management was particularly pleased with the low level of support required for the system after go-live, and a survey of the users showed a rise in user satisfaction from 17% before the implementation to 86% when using CARA.

The Benefits

The ability to have global users collaborating on creation and submission of dossier documents was a major advantage from the system.

CARA provided the functionality to create complex document structures and work with large numbers of documents with good performance.

User satisfaction with the system, and improved efficiency, was high.