Safety software validation is a fundamental phase to ensure that safety functions controlled by programmable logic (e.g., safety PLCs, configurable safety relays) are correctly designed, implemented, and compliant with applicable standards (EN ISO 13849-1, EN ISO 13849-2, EN IEC 62061, IEC 61508), and that they operate correctly under all conditions, including faults, restarts, and resets.
Validation is based on a structured methodological approach (V-model), which allows tracking every phase of development, verification, and testing, ensuring maximum transparency and reliability.
The service is structured in the following phases:
1. Analysis of Safety Requirements
- Review of the functional requirements of the Safety Functions;
- Identification of required levels (PL r or SIL), verification of traceability between specifications and analysis;
- Risk assessment and software implementation.
2. Software Verification (Preliminary)
- Analysis of programmed logic (Ladder, FBD, ST);
- Verification of correct hardware parameterization (trigger, redundancy);
- Control of certified libraries and standard function blocks;
- Verification of correct management of safety HW cuts in electrical diagrams;
- Verification of correct implementation of all safety functions identified in the risk analysis and requirements.
3. Software Lifecycle Control
- Version management, change traceability, revision identification;
- Application of secure development practices, documentation, and quality control;
- Alignment with the lifecycle required by reference standards.
4. Testing and Simulations
- Visual verification of correct installation and positioning of physical protection devices (guards, perimeter protections, etc.) and correct subdivision of safety zones.
- Execution of functional tests on site:
- Detailed verification of safety devices (interlock devices, sensors, light curtains, laser scanners, two-hand control devices, emergency stop buttons, etc.);
- Verification of correct management of HW + SW cuts in different safety zones and interlock management;
- Verification of stopping times for hazardous movements (electric, pneumatic, hydraulic, etc.);
- Verification of specific safety functions (e.g., SLS).
- System testing: verification that all overall functional and safety requirements are met;
- Robustness testing: assessment of behavior in case of abnormal inputs or faults;
- Performance testing: monitoring cycle times and real-time reactions;
- Verification of return to safe state after interruptions or restarts.
The following will be provided:
- Preliminary verification report, indicating any modifications to be made before on-site testing (if validation is performed on a new machine/plant).
- Detailed validation report with attachments:
- Regulatory checklists (EN ISO 13849-2 or EN IEC 62061)
- Test reports
- Report with indications of any non-conformities found and recommendations for corrections.
WE FOLLOW ALL STAGES OF THE PROJECT FROM RISK ANALYSIS TO SAFE PLANT COMMISSIONING.
Due Diligence Machinery Park
Documentation conformity check, audit at the client’s premises and drafting of the report which identifies obvious faults and suggest solutions for mitigation and an approximate budget.
CE Audit
Technical and documentary inspection aimed at verifying the conformity of the machinery with the requirements of the Machinery Directive 2006/42/EC.
Risk Assessment
Identification and analysis of hazards, risk assessment and definition of simplified or UNI EN ISO 12100 conformant mitigation measures.
Safety Design
Design of safety components and safety logic systems required for upgrading, drawings, component list, maintenance schedule.
Safety Compliance
According to the safety design, technical intervention on the machinery to restore conformity and trial run.
Safety Function Validation
Execution of the validation process for safety systems and protective measures implemented on machinery or production lines, in compliance with current regulations and standards.
Determination and calculation of safety function performance and safety matrix
Execution of analysis, design, and verification of the safety functions of machines and plants, in accordance with the EN ISO 13849-1 standard, and preparation of the Safety Matrix for mapping safety measures.
Safety software validation
Execution of the safety software validation process, aimed at ensuring that functions controlled by programmable logic are correctly designed, implemented, and compliant with applicable standards.
CE Marking
Support in drafting and collecting all relevant documentation to achieve CE marking.
Electrical equipment services for machinery
Complete solutions for the construction of electrical panels and safety control panels, with inspections and designs aimed at ensuring safety, reliability, and full compliance with European regulations and international standards.
DUE DILIGENCE MACHINERY PARK
RISK ASSESSMENT
SAFETY DESIGN
SAFETY COMPLIANCE
SAFETY FUNCTION VALIDATION
