CASE: INSIFE – PHARMACOVIGILANCE OG COMPLIANCE IN THE CLOUD

Delivering the required meticulous compliance within pharmacovigilance is a comprehensive and resource-heavy task. However, with digitization and the development of tailored digital solutions the workload has been significantly lifted and output improved. To one of Europe’s leading suppliers of pharmacovigilance software, cloud migration has realized the full potential.

CHALLENGE: PHARMACOVIGILANCE

Pharmacovigilance is the collective term for drug safety monitoring. Everyone associated with the life science industry is required to continuously monitor, collect, and report information on the safety of their products and any side effects.

Digitization has meant that pharmacovigilance has become significantly easier and more effective, but digital support can be a costly affair and administratively difficult to manage in terms of compliance. In addition, there are frequent upgrades and changes in legislation both nationally and internationally.

CLIENT: INSIFE

This prompted the Danish company Insife to launch a digital service tailored to the life science industry. A service which curates the best solutions from other suppliers (best-of-breed) as well as the company’s own. All on one platform.

However, the company quickly experienced challenges in terms of lack of agility, time-to-market, and very long onboarding time for new clients. On the customer side, demands for investment in infrastructure and maintenance of applications were a growing burden both financially and administratively.

Therefore, Insife decided to convert the service to a SaaS solution in AWS Cloud. With KeyCore as the AWS-partner.

The challenge was that both cloud and the services used had to meet the very strict regulatory requirements imposed on the pharmaceutical industry both in relation to compliance and safety.

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 assured that everything below the hypervisor line fully adheres to the strict compliance regime that all life-science actors must follow 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 standards – as well as the company’s self-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 investment in infrastructure.

KeyCore also assisted in the development 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 process for full compliance.

Compared to when customers previously had to use an on-premise implementation of applications, the cloud migration meant that the onboarding time has gone from months to hours.

AWS Technology

  • 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
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