What is a validation system?
A validation system is a planned, evidence-based process used to establish whether a system, product or service fulfils its intended purpose and applicable system or stakeholder requirements in its operating environment throughout the system life cycle.
At a glance:
- A validation action identifies the element and expected result, obtains and compares a result, assesses compliance and decides acceptability.
- Evidence can build from element-level activities through complete integrated-system validation and operational validation in the environment of use.
- Inspection, analysis, simulation, testing and demonstration may support validation, but the purpose remains intended use and applicable requirements.
- End-of-line systems can include barcode scanning and vision inspection, while system validation remains a separate assessment of intended use and requirements.
System validation in general engineering focuses on intended use and applicable requirements across the system life cycle. Computerised system validation in pharmaceutical GMP contexts has additional requirements and terminology specific to that application.
How is a validation action structured?
The process follows a repeatable evidence-and-comparison sequence. It starts with the element under assessment and its comparison reference. The assessor then uses suitable evidence to assess compliance and decide if the outcome is acceptable.
Assessment inputs and expected results
The first input is the element being assessed, which may be a system, product, service or another defined element. This element is considered against its purpose and functions, intended use, or requirements set by the system and its stakeholders, depending on the validation reference.
The expected-result reference supplies the point against which results are judged. It ties directly to what the element must achieve in the environment where it will be used, as well as the expectations of users or stakeholders, rather than only to system design.
Results, compliance and acceptability decision
The assessment then obtains results from the element. These results may come from inspection, analysis, simulation, testing or demonstration. In an end-of-line identification process, fixed mount barcode scanners provide hands-free barcode reading as a distinct function, separate from validation.
The results are compared with the reference. The assessor then assesses compliance and makes an acceptability decision. Validation evidence is interpreted against intended purpose, requirements and operating context, rather than relying only on final testing.
When does validation occur in the system life cycle?
Validation can begin before the complete system is ready and continue into operation. This life-cycle view links lower-level evidence, integrated-system assessment and confirmation in the setting where intended use occurs.
Element-level and integrated-system validation
Evidence may accumulate from validation activities at the element level during development. Those results contribute to the later assessment, but they do not replace validation of the integrated system. This is because lower-level evidence concerns individual elements rather than the assembled system.
Final validation considers the complete integrated system in an industrial environment. In an end-of-line automation setting, the integrated arrangement may include product handling, labelling or coding, inspection or verification, and reject functions as connected line stages.
Results accumulated during earlier element-level activities can form part of the evidence considered during final validation.
Operational validation in the context of use
Operational validation takes place in the operational environment, where the system is considered during use. Its reference remains the intended purpose and relevant requirements from the system and stakeholders, rather than the design alone.
The operational setting adds evidence about the system as it is used. Operational validation extends the life-cycle assessment beyond development and integrated-system activities, while keeping the decision connected to intended purpose.
Use this approach when a system, product or service must be assessed against its intended purpose, applicable requirements from the system and stakeholders, and the environment in which it operates. In production settings, this can mean assessing the integrated arrangement rather than treating a single scanner, inspection device or verification step as validation of the complete system.
How does system validation differ from system verification?
System verification checks conformity with design or specified requirements, while system validation asks whether the result serves its intended use. The two activities can use similar techniques, but they answer different questions about a system.
Purpose and context of use
Validation takes a global, end-user-oriented view. It considers the system in its intended context of use and assesses whether the result produces the expected effect there, across the system or service as a whole.
Verification is generally more local and detail-focused. It concentrates on conformity with system design or specified requirements rather than assessing the wider operating context and expected effect.
A vision inspection system can inspect specific product, label or code conditions on a production line, but that inspection function does not by itself establish that the wider system fulfils its intended use.
Requirements, design and complementary activities
For validation, the comparison references can include system requirements and stakeholder requirements. The assessment connects those requirements with intended use, so a result can be considered in relation to the system purpose, users and operating context it is meant to serve.
In an end-of-line application, identification systems can include barcode scanning and vision equipment, while system validation remains a separate assessment of the integrated line’s intended use.
For verification, system design or specified requirements provide the reference. Validation and verification remain separate but complementary activities, and they can use techniques such as testing, analysis, inspection, demonstration or simulation. Passing verification alone does not establish that the system fulfils its intended use.
ALS Identify inspection and identification systems remain distinct from system validation
System validation assesses intended use across the integrated system. ALS Identify designs and integrates end-of-line labelling, identification, vision and conveyor systems, while formal system validation remains a separate assessment against intended use and applicable requirements.
To discuss the equipment and integration requirements around an end-of-line identification or inspection project, contact ALS Identify.
