Validation Support for Process Equipment and Production Systems
Tanlet provides validation support for process equipment and production systems used in regulated manufacturing. The scope covers validation planning, risk management, testing, commissioning and qualification activities, with documentation prepared around the project requirements and applicable GMP standards.
Validation Planning and Risk Management
Validation starts with the project requirements and quality objectives.
Tanlet supports validation planning, GMP risk assessment, design review and quality control throughout the project. Key equipment functions, process risks and critical parameters are identified and incorporated into the validation approach.
Factory Acceptance Testing
Factory Acceptance Testing (FAT) verifies equipment and system functions before shipment.
The testing covers equipment construction, component installation, instrumentation, control functions, operating sequences and other agreed technical requirements. Test results are recorded as part of the project documentation.
Site Acceptance Testing
Site Acceptance Testing (SAT) verifies the equipment and system after installation at the customer's facility.
The checks cover equipment connections, instruments, control functions, operating conditions and system interfaces to confirm that the installed system meets the agreed requirements.
Commissioning and Qualification
Tanlet supports commissioning and qualification activities after installation.
Commissioning confirms the operation of equipment, instruments and control systems under site conditions. Qualification activities cover IQ, OQ and PQ where these stages are included in the project validation plan.
Validation Documentation
Validation activities are supported by controlled project records and test documentation.
Documentation covers validation plans, risk assessments, FAT and SAT records, commissioning records, qualification documents and test results. The documents provide traceability from project requirements through testing and qualification.
GMP Quality Support
Tanlet supports GMP-related quality activities throughout equipment and system delivery.
The scope includes design review, risk management, technical documentation, training and quality control. These activities connect equipment design and manufacturing with the validation requirements of regulated production.
Technical Support
Tanlet also provides technical support during validation and project execution, including technical communication, 3D model review and construction quality inspection.
These activities help coordinate equipment, engineering and site teams during installation and validation.
Validation from Factory to Site
Tanlet connects factory testing, site installation, commissioning and qualification within the equipment delivery process.
The validation scope is coordinated with the equipment, engineering and automation requirements of the project.
