Application Lifecycle Management (ALM) combines all phases of software development - from requirements to delivery - in a consistent, traceable process. Integrated toolchains, clear traceability and a systematic approach allow you to maintain an overview at all times, even in complex projects.
Whether medical device development, digital health applications (DiGA) or software-intensive systems: ALM ensures structure, efficiency and compliance - compliant with ISO 13485, IEC 62304 or industry-specific specifications.
Structure, quality and traceability - your benefits with ALM
Structure, quality and traceability - your benefits with ALM
A well-thought-out ALM concept creates the framework for successful software development - traceable, scalable and regulatory compliant.
Your benefits at a glance:
Seamless traceability across the entire development process Requirements, design, tests and releases are seamlessly linked.
Central management of complex projects All participants work in a shared environment - with clear processes and roles.
Toolchain integration from requirements to release Existing tools are efficiently linked (e.g. Jira, Polarion, Codebeamer, Git).
Compliance with regulatory requirements ISO 13485, IEC 62304, MDR, FDA - ALM supports verification in audits.
Higher product quality through continuous control Errors are detected early, development cycles can be better planned.
Herausforderungen Automotive SPICE und wie sepp.med unterstützt
Herausforderungen Automotive SPICE und wie sepp.med unterstützt
Mastering ALM successfully - with sepp.med
Introducing or optimizing an ALM system can quickly become a challenge. Many companies struggle with unclear processes, inconsistent tools or a lack of end-to-end visibility.
Typical stumbling blocks:
Distributed tools without integration Media disruptions and manual handovers cause a lack of transparency and additional work.
No consistent traceability Requirements and tests cannot be reliably assigned.
Lack of ALM strategy or know-how No common understanding of how ALM can be embedded in existing processes.
Our solution: We support you in the selection, introduction and optimization of your ALM environment - tailored to your company size, industry and tools:
Toolchain analysis & selection of suitable tools Vendor-neutral on request - or specific for e.g. Polarion, Codebeamer, Jira.
Definition and implementation of end-to-end processes Agile, V-model or hybrid - we build a traceability structure that suits you.
Training & change management So that ALM is not only introduced, but also lived.
Learning algorithms, adaptive control systems, and intelligent evaluation functions. These AI components pose new challenges for classic ALM setups in regulated products. AI models can drift and change as a result of retraining, so they must be continuously monitored during operation.
Regulatory requirements such as the FDA’s Predetermined Change Control Plan (PCCP) or ISO/IEC 42001 stipulate that this lifecycle must be fully integrated into your ALM structure. Specifically, traceability must include not only requirements, code, and test cases, but also model versions, training data, and validation results.
We can help make your ALM fit for AI-based products by ensuring it is process-reliable, audit-proof, and compliant with standards.
ALM encompasses the holistic planning, control and tracking of all phases of software development - from requirement to release.
It creates traceability, ensures quality and simplifies compliance with regulatory requirements.
Together we analyze your existing environment, define processes and integrate tools step by step - with a practical approach and with a view to acceptance within the team.
For companies with complex software projects - especially in regulated sectors such as medical technology, pharmaceuticals, automotive or energy.
