SAP Cloud ALM in a Regulated Environment
- GxP and IT Expertise from a Single Source
- 30+ Years of Experience in Regulated Industries
- SAP Silver Partner
SAP Cloud ALM for Life Sciences
SAP Cloud ALM is SAP’s cloud-based application lifecycle management platform. It provides transparency and traceability throughout the entire lifecycle of SAP solutions—from implementation and testing to deployment and operations.
For pharmaceutical, biotechnology and medical technology companies, the key question is how SAP Cloud ALM can be integrated into the existing system and compliance architecture. The SAP standard does not automatically replace a complete validation solution.
DHC supports you in the assessment, design and implementation of a practical and regulatorily robust operating model.
Challenges of SAP Cloud ALM in Life Sciences
Lack of a clear target vision
Without a clearly defined scope, Cloud ALM use cases, system boundaries, interfaces and responsibilities remain unclear.
Separate toolchains
Separate tools for requirements, processes, testing and validation documents create redundancies and make traceability more difficult.
Release and change dynamics
Frequent cloud releases require an integrated, risk-based process for changes, testing and approvals.
SAP Cloud ALM in Practice: Benefits and Use Cases
SAP Cloud ALM supports the entire application lifecycle of SAP solutions – from implementation, testing and deployment to operations and service. For companies in the Life Sciences industry, the platform provides a central working environment in which project activities, processes, requirements, solution documentation, tests and changes can be brought together in a structured way.
A key benefit is end-to-end traceability: Requirements can be linked to processes, user stories, test cases and defects. This improves transparency throughout the project and provides a reliable basis for risk-based validation activities.
In a regulated environment, however, SAP Cloud ALM is not automatically a complete validation solution. GxP-relevant requirements, roles, approvals, document structures, electronic signatures, audit trails and change control must be considered in the operating concept and – where necessary – covered by suitable processes, configurations or complementary solutions.
Typical application areas:
- Implementation: Centrally manage project structures, processes, requirements, user stories, tests and defects.
- Traceability: Map relationships between requirements, processes, solution documentation and tests in a traceable manner.
- Deployment and changes: Plan and track releases, transports and changes in a structured way.
- Operations and service: Support the operation of the SAP landscape through integrated monitoring, service and lifecycle processes.
- Toolchain integration: Connect SAP Cloud ALM with SAP Signavio, SAP S/4HANA and other suitable systems and tools.
DHC supports you in defining the appropriate scope of application, incorporating regulatory requirements at an early stage and integrating SAP Cloud ALM into a practical IT and compliance architecture.
DHC Consulting Services for SAP Cloud ALM
Scoping, Compliance & Strategy
DHC assesses your current situation and develops a Cloud ALM target vision that brings together business, technical and regulatory requirements.
- Capturing and assessing processes, systems, interfaces and stakeholders
- Defining relevant Cloud ALM use cases for implementation, operations and service
- Considering GxP, Data Integrity, Audit Readiness, as well as change, test and release management
- Assessing the toolchain and potential integrations, for example with SAP Signavio
- Defining roles, responsibilities, scope and roadmap
Outcome: A clear basis for decision-making regarding the use of SAP Cloud ALM.
Solution Design & Implementation
- Designing the Cloud ALM project structure and relevant workflows
- Structuring processes, requirements, user stories, tests and defects
- Establishing test management and traceability for transparent project and compliance processes
- Designing deployment, transport, change and release processes
- Integrating Cloud ALM into the existing SAP and IT toolchain and assessing a potential migration from SAP Solution Manager
- Documenting the configuration and supporting the transition to operations
Enablement, Support & Operations
- Guidance workshops, quick reference guides and role-based enablement
- Support for business, IT, quality and implementation partners
- Support for change and release management as well as continuous process improvement
- Support for audit readiness, lifecycle documentation and compliance governance
- Consulting on the further development of the operating model and, where required, managed services
DHC Starter Packages for SAP Cloud ALM
From an initial overview to a concrete target vision: DHC offers three starter packages for the implementation and use of SAP Cloud ALM, with the appropriate level of detail for your specific starting point.
Cloud ALM Scope
The focused starting point: DHC analyses your objectives, stakeholders, ALM and IT processes, systems and interfaces, and prioritises the relevant Cloud ALM use cases for implementation, operations and service.
Outcome: Cloud ALM scope map, decision and action log, and workshop minutes.
Cloud ALM & Compliance
The scope is expanded to include GxP, compliance, as well as change, test and release management. DHC assesses how SAP Cloud ALM can be integrated into the existing system and process landscape and which additional measures are required.
Outcome: Compliance overview, Cloud ALM setup recommendation and roadmap guidance.
Cloud ALM Target Design
The in-depth end-to-end analysis of the Cloud ALM toolchain – including process modelling, interfaces, traceability, document management, test automation, the operating model and a potential migration from SAP Solution Manager.
Outcome: Assessment report, target design and implementation roadmap.
Would you like to learn more?
Digital Validation with SAP Cloud ALM and the DHC Smart Validation Accelerator
If your SAP project requires additional validation documentation, controlled approvals, electronic signatures or risk-based change control, the DHC Smart Validation Accelerator can complement SAP Cloud ALM in a targeted way.
The platform supports:
- structured creation of validation documentation
- consistent lifecycle documentation
- digital audit traceability
- efficient execution of complex ERP validations
→ Learn more about the DHC Smart Validation Accelerator
Why DHC for SAP Cloud ALM in Life Sciences?
For over 30 years, DHC has combined SAP, process and compliance expertise for companies in regulated industries. We support you in selecting suitable Cloud ALM use cases, designing and implementing the solution, and ensuring its sustainable use throughout your projects and operations.
- Expertise in SAP Cloud ALM, SAP Signavio and SAP S/4HANA
- Experience in GxP compliance, Data Integrity and Audit Readiness
- Practical, proven consulting for business, IT, quality and implementation partners
- Support from the initial scope assessment through ongoing operations
Your benefit: clear responsibilities, fewer redundancies and a Cloud ALM solution that fits your system landscape and organisation.
SAP Cloud ALM in a Regulated Environment
Are you assessing the use of SAP Cloud ALM, planning an SAP S/4HANA implementation or looking for an alternative to SAP Solution Manager? DHC will assess use cases, the toolchain, compliance requirements and the next steps together with you.
Frequently Asked Questions about SAP Cloud ALM in GxP-Regulated Environments
What tasks does SAP Cloud ALM perform?
SAP Cloud ALM supports the management of SAP implementations, process and solution documentation, requirements and test management, as well as deployment, operations and service.
Why is SAP Cloud ALM relevant for Life Sciences?
The platform provides a central and traceable working environment for SAP projects and can link requirements, processes, tests and changes.
Is SAP Cloud ALM suitable for use in GxP-regulated environments? Does it replace software validation?
In principle, yes. However, its use must be planned based on a risk-based approach and embedded into the existing system, process and compliance architecture.
Is standard SAP Cloud ALM sufficient for complete validation?
No. Depending on the specific use case, validation-specific document structures, electronic signatures, controlled approvals, end-to-end traceability and change control must be addressed through additional processes, configurations or complementary solutions.
When should SAP Cloud ALM be planned into an SAP project?
Preferably as early as the Explore and concept phases, so that use cases, roles, integrations and regulatory requirements can be defined at an early stage.
How does DHC support implementation?
DHC supports you from scoping and target vision through solution design and configuration to enablement, handover and ongoing use in projects and operations.
SAP Cloud ALM in a Regulated Environment
Are you assessing the use of SAP Cloud ALM, planning an SAP S/4HANA implementation or looking for an alternative to SAP Solution Manager? DHC will assess use cases, the toolchain, compliance requirements and the next steps together with you.