How Are Systems Validated for Regulated Environments?

Laboratories operating in regulated industries such as pharmaceuticals, biotechnology, medical devices, diagnostics and advanced manufacturing need confidence that their automation systems perform as intended, generate reliable data and support compliance requirements.

Validation is the process of demonstrating that a system consistently meets its intended purpose. For laboratory automation, this typically involves defined requirements, documented testing, acceptance criteria, risk management, traceable records and ongoing support throughout the system lifecycle.

At Labman, validation is built into the project delivery process, helping customers move from concept to routine operation with confidence.

Validation is the documented process of proving that an automated system performs consistently according to its intended use.

In regulated environments, validation helps ensure:

• Reliable and repeatable system performance
• Accurate and traceable data
• Compliance with relevant quality frameworks
• Confidence in results used for decision-making
• Reduced operational and regulatory risk

A well-validated automation system provides evidence that the technology has been designed, tested and commissioned against agreed requirements.

Labman follows a structured approach that links customer requirements to documented testing and acceptance activities.

This typically includes:

1. Defining system requirements and success criteria
2. Designing the system around those requirements
3. Performing Factory Acceptance Testing (FAT)
4. Installing and commissioning the system
5. Performing Site Acceptance Testing (SAT)
6. Resolving observations through change control
7. Providing documentation and ongoing support

The goal is not simply to build a machine, but to demonstrate that the system performs as agreed before it enters routine use.

Factory Acceptance Testing (FAT) is a formal testing phase conducted before the system leaves Labman’s facility.

The purpose of FAT is to verify that the system functions correctly against the agreed specification before shipment.

A typical FAT may include:

• Verification of workflow functionality
• Hardware and software testing
• User interface verification
• Data capture checks
• Error handling verification
• Integration testing
• Performance testing against acceptance criteria

Customers are often involved in reviewing or witnessing FAT activities, helping to ensure alignment before installation.

FAT helps identify issues early, reducing risk, delays and disruption during installation.

It provides confidence that:

• The system has been built correctly
• Requirements have been addressed
• Major functionality has been tested
• Evidence exists to support system acceptance

Site Acceptance Testing (SAT) takes place after delivery and installation at the customer’s facility.

The purpose of SAT is to confirm that the system performs correctly within its final operating environment.

SAT typically evaluates:

• System operation following installation
• Integration with site infrastructure
• Laboratory workflows
• User operation and training
• Environmental factors
• Consumables and process variability

Because every laboratory environment is different, SAT helps confirm that performance seen during FAT is maintained in real-world operation.

Even a fully functioning system may encounter new variables after installation.

Examples include:

• Different laboratory environments
• Variations in utilities and services
• Differences in consumables
• Changes in workflows
• Local operating procedures

When observations are identified, they are documented and managed through controlled review and resolution processes to ensure that any agreed actions are completed appropriately.

Labman has extensive experience delivering systems for GMP and highly regulated industries.

Depending on the application, systems may incorporate features such as:

• Structured validation testing
• Electronic data capture
• Audit trails
• Traceable process records
• Integration with LIMS and other quality systems
• Process monitoring and reporting
• Controlled access and user permissions

Labman’s automation solutions are used across pharmaceutical development, quality control, bioprocessing, manufacturing and medical technology applications.

Yes.

Where required by the application, Labman systems can support auditability through automated data capture and traceable records.

This may include:

• Recording user actions
• Capturing process events
• Logging workflow changes
• Maintaining historical records
• Integrating with wider quality systems

Audit trails help organisations understand what happened, when it happened and who performed specific actions.

Data integrity is a key consideration in regulated laboratory environments.

Labman systems can be designed to support:

• Accurate electronic data capture
• Traceable records
• Secure data storage
• Integration with LIMS, ELNs and enterprise systems
• Automated reporting
• API-based data transfer
• Standardised data formats

The objective is to ensure that information remains accessible, traceable and useful throughout the lifecycle of the system.

Changes are a normal part of automation projects.

Workflows evolve, requirements mature and opportunities for improvement emerge during implementation.

For regulated environments, changes should be controlled and documented so that modifications can be reviewed, assessed and tested appropriately before release.

Effective change control helps maintain system quality while allowing projects to adapt when necessary.

The exact documentation depends on the project’s scope and regulatory requirements, but may include:

• User requirements
• Functional specifications
• Design documentation
• Test protocols
• FAT records
• SAT records
• Change records
• Operating manuals
• Maintenance documentation
• Training materials

Together, these documents provide evidence of how the system was designed, tested, installed and supported.

Successful validation is collaborative.

Laboratory teams typically contribute by:

• Defining requirements
• Reviewing workflows
• Participating in acceptance testing
• Supporting site integration activities
• Reviewing documentation
• Providing approval where required

Bringing together scientific, engineering, QA, IT and operational stakeholders early in the project often leads to smoother validation and faster adoption.

No.

While validation is often associated with pharmaceutical GMP environments, structured validation can benefit any laboratory where reliability, traceability and repeatability are important.

This includes:

• Biotechnology
• Cell and gene therapy
• Medical devices
• Diagnostics
• Advanced materials
• Chemicals
• Food and beverage
• Academic research
• Industrial manufacturing

Any organisation relying on automated data and critical laboratory processes can benefit from a documented validation approach.

A strong automation partner should be able to:

• Translate requirements into testable outcomes
• Define clear acceptance criteria
• Conduct structured FAT and SAT activities
• Provide transparent documentation
• Support change control
• Integrate with existing quality systems
• Provide ongoing support after installation

Most importantly, they should view validation as part of the entire project lifecycle rather than a final hurdle before handover.

Systems used in regulated environments must do more than function correctly — they must be able to demonstrate that they function correctly.

Labman’s approach combines structured testing, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), documentation, traceability, change control and long-term support to help customers deploy automation with confidence.

For laboratories working in regulated industries, validation is not a separate activity from automation. It is an integral part of delivering reliable, auditable and scalable laboratory technology.