Industry Compliance Management
Service
Compliance Consulting for ISO 13485, 14971, 26262, ASPICE, IEC 62443, R155
Anselm builds a digital compliance core through a “PLM + ALM/RM dual-platform collaboration” approach. This ensures that every requirement, risk item, verification activity, and engineering change in the R&D process is fully traceable, reproducible, and aligned with international audit standards.
We help enterprises shift compliance from “document-heavy reporting” to a system-driven evidence chain.
Medical Device (ISO13485/14971)Automotive Functional Safety (ISO 26262)Automotive System Development Capability Assessment (ASPICE)Aerospace & Defense Compliance (AS9100)
Medical Device: End-to-End Compliance from Design to Production Records
Medical device development faces increasingly strict regulatory requirements, including ISO 13485:2016, ISO 14971:2019, and FDA 21 CFR Part 820.
Anson Information applies a dual-platform architecture to seamlessly integrate hardware documentation and software lifecycle management, eliminating compliance blind spots.
Systematic Compliance Capabilities
| Standard | Oracle Agile PLM / Teamcenter PLM / Polarion ALM / Jama Connect RM | Core Value |
| Design Control (ISO 13485 Clause 7.3) | PLM as Single Source of Truth (SSOT): Centralized management of DHF (Design History File) and DMR (Device Master Record). The system automatically links drawings, specifications, and ECO change history, ensuring a complete and auditable trail. |
Value: Always audit-ready, significantly reducing preparation time and error rates during FDA/ISO inspections. |
| Risk Management (ISO 14971) |
Polarion Dynamic Risk Matrix: |
Value: Risk visualization ensures all unacceptable risks are mitigated and properly verified. |
| Software Lifecycle (IEC 62304) | Live Traceability (End-to-End Traceability): Establishes a full traceability chain from user requirements → software requirements → code → testing → risk management, meeting strict SaMD (Software as a Medical Device) requirements. |
Value: Accelerates time-to-market by reducing R&D cycle time by approximately 15%–30%. |
Driving the V-Model for Systematic Vehicle Safety Assurance
As automotive electronics and software continue to grow in complexity, functional safety has become a non-negotiable requirement for OEMs and Tier-1 suppliers. Based on ISO 26262:2018, Anson Information integrates PLM × ALM platforms to help organizations establish a full lifecycle functional safety management system covering concept, system, hardware, and software domains. This ensures that the V-Model is not only documented but also truly implemented within systems and processes.
I. Core Challenges and Anson’s Approach
Key Challenges in Automotive Functional Safety
- Development processes span system, hardware, and software domains, leading to fragmented and siloed data
- Different ASIL levels increase complexity in verification and audit processes
- Lack of real-time traceability between requirements, design, and testing
- Difficulty in rapidly assessing change impacts, creating potential safety risks
Anselm’s Solution
Anselm builds a digital functional safety platform compliant with ISO 26262 by integrating PLM (Oracle Agile PLM / Teamcenter) and ALM (Polarion).
This ensures:
- End-to-end functional safety activities are executable and fully traceable
- Safety evidence is automatically generated and continuously accumulated for audits and assessments
- Changes are controlled with real-time risk identification and impact analysis
II. Functional Safety Implementation Details
Safety Lifecycle Management (ISO 26262 Part 2 / Parts 3–6)
Implementation Approach
Within PLM / ALM systems, ASIL (Automotive Safety Integrity Level) attributes are defined and enforced to drive the functional safety process.
- ASIL levels are assigned and managed directly within PLM / ALM data models
- The system enforces corresponding verification workflows, review gates, and independence requirements based on ASIL classification
- A complete Safety Case is established to centrally manage all functional safety evidence and documentation
Tool Support and Qualification
For platforms such as Oracle Agile PLM, Teamcenter, and Polarion, Anson Information provides:
- Tool Qualification (ISO 26262 Parts 8–11) support
- Tool Classification Level (TCL) assessment documentation
- Validation packages ensuring tool suitability, reliability, and compliance within safety-critical workflows
This ensures that the tools themselves are formally qualified and accepted as part of the functional safety lifecycle.
ASPICE Compliance Engine: Building Level 3 Capability Development Processes
ASPICE Compliance Engine: Building a Level 3 Capability Development Process
A Digital Compliance Engineering System Based on ASPICE v4.0
Anselm leverages ASPICE (Automotive SPICE) v4.0 as a core framework to build a fully digital compliance engineering system for automotive software and electronics development.
ASPICE has become a key evaluation standard for automotive electronics and software development. By integrating systems engineering, software engineering, hardware engineering, and mechanical engineering, Anson helps organizations establish a V-model–compliant digital development and verification framework.
Through a PLM + ALM cross-domain integration architecture, compliance requirements are not only used for audits, but are transformed into daily executable, measurable, and continuously optimizable engineering processes.
System & Software (Polarion)
Manages the full lifecycle from:
- Requirements elicitation (SYS.1)
- System engineering and validation
- Software development and verification (SWE.1 – SWE.6)
This ensures full end-to-end traceability and process enforcement across the software lifecycle.
Hardware & Mechanical (Teamcenter / PLM)
Manages:
- Hardware BOM and design lifecycle
- Design verification activities (HWE.1 – HWE.4)
- Integration with IATF 16949 quality management principles
This enables synchronized development between mechanical, electrical, and software domains.
Target Objective
Achieve ASPICE Established Level 3 capability, ensuring that engineering processes are:
- Repeatable
- Well-defined
- Consistently controlled across projects
By combining PLM and ALM into a unified compliance engine, Anselm enables enterprises to operationalize ASPICE rather than treat it as a one-time assessment requirement.
I. Cross-Domain Integration Architecture (Plug-in Concept)
Connecting SYS / SWE / HWE into a Unified Digital Thread
Systems & Software Engineering (SYS / SWE)
Using Polarion as the core ALM platform, the following processes are fully digitized and managed:
- Systems engineering lifecycle (SYS.1 – SYS.5)
- Software engineering lifecycle (SWE.1 – SWE.6)
- Requirements elicitation, decomposition, design, verification, and testing
- Live Traceability™ (real-time bidirectional traceability)
Hardware & Mechanical Engineering (HWE)
Managed through Teamcenter and Oracle Agile PLM, covering:
- Hardware BOM and product structure management
- Version control, baselines, and engineering change management
- Hardware design verification and cross-functional collaboration (HWE.1 – HWE.4)
II. Live Traceability™ Real-Time Bidirectional Traceability
At the core of the solution, Polarion Live Traceability™ establishes a complete end-to-end traceability chain:
- Stakeholder Requirements (SYS.1)
→ System Requirements (SYS.2)
→ System Architecture (SYS.3)
→ Software Requirements (SWE.1)
→ Code and Test Results (SWE.4 / SWE.6)
Every requirement and every test result can be traced back to its origin and analyzed for impact scope, effectively preventing unintended functionality and reducing safety risks.
III. Consistency Management
The system enforces automated consistency control across engineering artifacts:
- Detects conflicts between requirements (Internal Consistency checking)
- Ensures semantic and logical alignment between design and requirements
- Automatically flags Suspect Links when upstream requirements change
- Enforces mandatory Impact Analysis to ensure changes do not violate compliance or system integrity
Driving Compliance Excellence in Aerospace & Defense through PLM/ALM
Anselm leverages a PLM/ALM-driven approach to enable compliance excellence for the Aerospace, Space, and Defense (ASD) industry.
Designed specifically for highly regulated ASD environments, this solution goes beyond ISO 9001 requirements and helps organizations build a fully digital management system aligned with the stringent demands of AS9100 Aerospace Quality Management Standard.
Hardware Compliance Core (PLM)
Platform: Oracle Agile PLM / Teamcenter
Value:
Focused on hardware product configuration management and end-to-end control of the product realization process, ensuring full traceability down to every single component—down to each screw.
Software Compliance Core (ALM)
Platform: Polarion ALM / RM
Value:
Focused on compliance requirements for deliverable software in avionics and embedded systems. In alignment with the principles of AS9115, it enables precise traceability from requirements to code, ensuring full control, verification, and compliance across the software lifecycle.
Core Benefits of the Solution
- Establish a Digital Thread: Break down data silos across design, engineering, manufacturing, and quality domains by implementing a fully connected digital thread. This enables seamless end-to-end data flow across the entire product lifecycle.
- Embed Risk-Based Thinking: Move away from reactive corrective actions by embedding risk assessment early into the lifecycle. Risk management becomes an integral part of the product development process, ensuring issues are identified and mitigated proactively.
- Supply Chain Transparency: Ensure complex technical specifications and quality requirements are accurately and consistently communicated to all levels of the supply chain, improving execution accuracy, compliance, and collaboration with suppliers.
