Validation

Satisfy internal and government requirements with process validation for medical device manufacturing. Ensure your entire system and the EOL deliverable meet government requirements.

Capabilities / Validation

Validation

Satisfy internal and government requirements with process validation for medical device manufacturing. Ensure your entire system and the EOL deliverable meet government requirements.

Data Validation Automation Tools

Data Validation Automation Tools

Extensive Industry Experience

Verify Product Quality

Verify Product Quality

Before introducing a new medical device into the market, manufacturers need to have a high degree of certainty that their processes have the proper controls to meet applicable standards and requirements.

The Lanco process for validation of medical device assembly systems meets the highest demands of the industry. Our engineers develop US FDA and ISO 13485 compliant processes. Process validation goes hand-in-hand with process control, and you get industry leading guidance in both from Lanco. You’ll benefit from our long-term plan and strategy.

Maintain compliance with a complete GAMP® 5 validation process that includes:

  • Design Qualification (DQ)

  • Installation Qualification (IQ)

  • Safety Qualification (SQ)

  • Operational Qualification (OQ)

Extensive Industry Experience

Partner with a Global Leader

Guarantee Product Integrity Every Time

From forming your initial validation team all the way to any necessary revalidation steps, we partner with you to assist in the creation of a comprehensive validation plan. Our automated systems reduce labor and ensure consistency in the execution of your plan. Rely on our decades of expertise with medical automation. Medical manufacturing plants around the world lean on us for compliance.

  • US FDA & ISO 13485 Compliant Processes

  • Safety Qualification (SQ)

  • Comprehensive Validation Planning

  • GAMP® 5 Validation Framework

  • Installation Qualification (IQ)

  • Revalidation Support

  • Design Qualification (DQ)

  • Operational Qualification (OQ)

  • Documentation & Traceability

Validation Resources

Inspection & Testing Resources

Design for Automation (DfA)

DfA builds automation into the product development process from the start, ensuring designs are optimized for automated assembly, testing, and manufacturing. The result is a faster production ramp, lower costs, reduced risk, and stronger ROI…

S3: Service, Support, Spares

To provide fast, accurate, and proactive support that keeps customers’ systems and equipment running safely and reliably by resolving issues efficiently, communicating clearly, and building long-term trust through consistent, high-quality service…

Medical Device & Diagnostics

Modular Diagnostic Testing Solutions & Automated Workflow Systems

– Instant, rapid and extended molecular and antigen test kits
– Semi-automated and fully automated process systems with data management SW…

Benefits of Our Validation Process

Benefits of Our Validation Process

Document Validation Steps

The US FDA requires documentation of your process validation. Process validation reduces the labor involved in generating that documentation. This critical step is customized for your specific requirements.

Satisfy Regulations

Right now, our validation processes help companies comply with stringent rules from dozens of regulatory agencies around the world. Our validation process includes DQ, SQ, IQ, and OQ to meet the respective FDA and TÜV requirements.

Build a Partnership

With our Total Service Solution, the process validation system we build for you is the foundation for a lasting partnership invested in your success. Produce your medical device supported by highly credentialed automation engineers across the globe, dedicated to ensuring you achieve the highest outputs within all applicable regulations.

Affiliations

Affiliations

ISO 9001:2015 Certified by NQA

Contact Our Global Sales Team

Contact Our Global Sales Team

Lanco applies more than 60 years of manufacturing experience to develop custom automated test and inspection solutions. Speak with a member of our global sales team to learn more about the impact inspection automation can have on your quality and output.