Distek is committed to providing its customers with the most consistent, traceable results needed to satisfy regulatory requirements. Much like our philosophy for designing quality instruments, Distek’s Validation Service Group utilizes highly skilled chemists and technicians that undergo comprehensive training and certification in all aspects of validation services. Our product is our people, each of which has an unparalleled commitment to both customer service and assuring that your instrument is performing according to industry specifications.
- Installation Qualification (IQ) – Assuring that your system is received in good condition, IQ will verify the system meets specifications as well as certifies the system is set up and installed correctly, in the right environment and ready for operational qualifications and performance qualifications.
- Mechanical Qualification (MQ) - Certification that the mechanical performance of the system is satisfactory and that the system is available for further performance qualification.
- Performance Verification Test (PVT) – Ensures the system is working properly and both verifies and certifies the instrument meets system suitability test requirements per USP <711> guidelines using USP calibrator tablets and reference standards.
- Multi-Vendor Services - Provides expertise and qualification services for Distek and non-Distek equipment. Contact Distek for specific instrument services.
- Preventative Maintenance (PM) - Servicing of equipment to confirm continued proper operation per the manufacturer’s specifications including the replacement of parts, inspection and replacement of electronic components, connections, switches, motors and more.
- Operational Qualification / Performance Verification (OQ / PV) - Verifies the system is functioning and that all critical operational parameters are within specifications while supplying the evidence needed to meet the requirements of regulatory agencies and makes certain your laboratory equipment performs within specified guidelines.
- SOP Writing - Saving valuable time and money, the validation services team will write your SOP’s to qualify your instruments as well as train your staff to execute them.
- Validation Contracts - Eliminate worry while keeping costs down.
- Maintenance, Repair and Training
Distek offers validation services for different instruments as listed in the table below.
For more information, please contact Distek.