Validation and Qualification

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 had an unparalleled commitment to both customer service and assuring that your instrument is performing according to industry specifications.

Installation Qualification (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 meets specifications and that the system is available for further performance qualification.
Performance Verification Test (PVT) Ensures the system meets system suitability test requirements per USP <711> guidelines using USP tablets and reference standards.
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.
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.
Multi-Vendor Services Provides expertise and qualification services for Distek and non-Distek equipment. Contact Distek for specific instrument services.
SOP Writing Saving valuable time and money, the validation services team can provide SOP’s to qualify your instruments as well as train your staff to execute them.
Validation Contracts Eliminate worry while keeping costs down.
On-site or Deport Repair Factory trained specialist who can provide repair at your lab or in our facility.
Training Familiarization of your laboratory instrument delivered to one or many lab personnel.

All services may be customized to meet specific requirements. For more information, please contact your Distek representative or complete and submit the Service and Support Contact Form.

Instrument type*	IQ	PM	OQ	PV	PVT	USP Toolkit MQ	ASTM-MQ
Content Uniformity	Yes	Yes	Yes	-	-	-	-
Dissolution
Apparatus 1 and 2	Yes	Yes	-	-	Yes	Yes	Yes
Apparatus 3 and 7	Yes	Yes	-	-	-	-	-
Dissolution Auto Sampler	Yes	Yes	Yes	-	-	-	-
Dissolution Media Preparation	Yes	Yes	Yes	-	-	-	-
Dissolution Vessel Washer	Yes	Yes	Yes	-	-	-	-
Disintegration	Yes	Yes	Yes	-	-	-	-
Friability	Yes	Yes	Yes	-	-	-	-
Hardness	Yes	Yes	Yes	-	-	-	-
Tapped Density	Yes	Yes	Yes	-	-	-	-
UV Fiber Optic Dissolution	Yes	Yes	Yes	Yes	-	-	-
UV/Vis Spectrophotometer	Yes	Yes	Yes	Yes	-	-	-

Instrument type*

PVT

USP Toolkit MQ

ASTM-MQ

Content Uniformity

Yes

Dissolution

Apparatus 1 and 2

Yes

Apparatus 3 and 7

Yes

Dissolution Auto Sampler

Yes

Dissolution Media Preparation

Yes

Dissolution Vessel Washer

Yes

Disintegration

Yes

Friability

Yes

Hardness

Yes

Tapped Density

Yes

UV Fiber Optic Dissolution

Yes

UV/Vis Spectrophotometer

Yes

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