Complying with the rules for pharmacovigilance is a very extensive task, but with increased digitization and the development of software, compliance has become both better and easier to manage. For one of Europe’s leading suppliers, a cloud migration has realized its full potential.
CHALLENGE: Pharmacovigilance
Pharmacovigilance is the collective term for monitoring the safety of medicinal products. All players in the pharmaceutical industry are obliged to continuously check, collect and disseminate information about the safety of their products and any side effects.
Digitization has meant that pharmacovigilance has become significantly easier and more efficient, but the digital support can be a costly affair and administratively difficult to lift in relation to compliance. In addition, there are frequent tightenings and changes to legislation both nationally and internationally.
CUSTOMER: Insife
This prompted the Danish company Insife to launch a service for players in the pharmaceutical industry. A service that curated the best solutions from other suppliers (best-of-breed) as well as the company’s own in one place.
However, the company quickly experienced challenges in terms of lack of agility, time-to-market and very long onboarding time for new customers. On the customer side, demands for investment in infrastructure and maintenance of applications were a growing burden both financially and administratively.
Together with KeyCore, Insife therefore moved the business to a SaaS solution in the AWS Cloud.
The challenge was that the cloud and the services used had to meet the very strict regulatory requirements placed on the pharmaceutical industry both in relation to compliance and security.
SOLUTION
KeyCore assisted in establishing a secure, robust and scalable cloud infrastructure in AWS that is both HIIPA, GxP and GDPR compliant, which is license-to-operate for the company.
The choice of AWS was closely related to the very high level of compliance. With AWS, Insife is ensured that everything below the hypervisor line fully meets the strict compliance regime that all life-science players must comply with internationally.
The solution is designed to ensure maximum security and separation of the individual end customers, without this increasing management overhead for the company. This applies to both already established industry-specific standard applications as well as the company’s own developed applications.
The solution enables Insife’s customers to use all services as SaaS. This means that they can use all relevant applications without costly investments in infrastructure.
KeyCore also assisted with the preparation of templates for a scalable infrastructure that ensures easy and efficient onboarding of new customers in a replicable set-up that complies with the regulatory requirements for life science.
Similarly, CI/CD pipelines via templates are optimized for fast and efficient execution with carefully described policies and processes for full compliance.
Compared to when customers previously had to use an on-premise implementation of applications, the transformation to the cloud meant that the onboarding time has gone from months to hours.
AWS technology used:
- Multi Account Organizational policies
- IAM / Federation
- VPC with advanced Peering
- CloudFormation
- Managed Active Directory
- Advanced Windows management
- RDS / Oracle
- AutoScaling
- System Manager (SSM)
- EC2 Automation
- LoadBalancing