Life sciences and regulated operations
Regulated Cloud Data & AI Trans-formation
Structuring an AWS-based target architecture and qualification approach for Data & AI and enterprise integration platforms.
Context
A regulated organisation initiated a strategic move to establish its Data & AI platform in AWS, including Databricks and enterprise integration capabilities within a qualified cloud foundation.
Challenge
The transformation required coordinated decisions across the AWS landing zone, organisational account structure, identity, networking, security controls, Databricks workspaces, integration runtimes, qualification scope, evidence and operating responsibilities.
Mandate
Develop the target architecture and integrated workstream approach needed to move from a high-level mandate to a secure, qualified and executable platform programme.
Approach
- 01
Structured the AWS organisation and account model around security, infrastructure and regulated platform domains.
- 02
Defined platform boundaries and dependencies between the landing zone, Databricks and enterprise integration services.
- 03
Separated platform qualification responsibilities from use-case validation responsibilities.
- 04
Mapped identity, networking, logging, encryption, backup, evidence and change-control requirements into the target design.
- 05
Created integrated planning for architecture, build, qualification, operational readiness and migration.
Capabilities established
- AWS organisation and landing-zone target model
- Databricks-on-AWS architecture
- Enterprise integration runtime architecture
- GxP scope and qualification boundaries
- Integrated security, compliance and delivery workstreams
Impact
- Converted a broad cloud mandate into explicit architecture decisions and workstreams.
- Clarified dependencies between platform engineering, security, compliance and application delivery.
- Created a basis for qualification evidence and production readiness from the beginning of the programme.
- Reduced the risk of building a technically functional platform that could not be approved or operated sustainably.
Transferable lessonIn a regulated cloud programme, qualification cannot be added after the architecture is built. The control model, evidence flow and operational responsibilities must shape the target architecture from the outset.
Contact
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