Validation
V:KIT is a unique and independent system for qualifying analytical instruments.
It’s a system for the OQ/PQ qualification of HPLC, GC and GCMS, also tablet dissolution instruments and processes. V:KIT is designed to fit all needs, from the smallest to the largest organisation.
Validation
We are dedicated to providing the tools, protocols and procedures, software and standards to help you achieve regulatory compliance in the laboratory.
HPLC V:KIT protocols include:
GCMS V:KIT protocols include:
- Mass Accuracy test
- Signal to noise test
- Autosampler precision/mass ratio test
- RFPA test (suitable for Agilent MS only)
- Column oven, inlet and detector temperature accuracy & stability
- Inlet pressure accuracy and tightness
- Inlet and detector flow accuracy (inc. split, purge)
- Autosampler injection precision, carryover and retention time reproducibility
GC V:KIT protocols include:
- Column oven, inlet detector and detector temperature accuracy
- Column oven, inlet and detector temperature stability
- Inlet pressure accuracy and tightness
- Inlet and detector flow accuracy (including split, purge, make-up, fuel gases
- Autosampler injection precision, carryover and retention-time reproducibility
- Detector response linearity (FID/TCD)
We are dedicated to providing the tools, protocols and procedures, software and standards to help you achieve regulatory compliance in the laboratory.
What Is Validation?
What does V:KIT consist of?
Suitably trained personnel can use V:KIT as a tool to provide instrument qualification in regulated laboratories, such as those inspected by the FDA
What do I need to get started? Use the Contact Us page to tell us your requirements. We can advise on the software platform best suited to your needs, and the correct choice of kits to suit your instrument configurations.
What are the benefits of using V:KIT?
- Windows-based software to create and manage qualification protocols, and deliver controlled consistent qualification tests
- Traceable chemical reference standards
- Standard operating procedures
Suitably trained personnel can use V:KIT as a tool to provide instrument qualification in regulated laboratories, such as those inspected by the FDA
What do I need to get started? Use the Contact Us page to tell us your requirements. We can advise on the software platform best suited to your needs, and the correct choice of kits to suit your instrument configurations.
What are the benefits of using V:KIT?
- There many benefits include efficiency, consistency and compliance:
- V:KIT uses one standard approach – regardless of instrument manufacturer, providing the potential of consistent performance across all your equipment on all sites
- V:KIT provides the potential for your metrology group, service provider, or analysts to perform qualifications
- Control – you can define qualification protocols to meet your own requirements
- The user-friendly software, SOPs, and reference standards work seamlessly together
- Used correctly, V:KIT can aid compliance to regulations issued by international authorities such as FDA (USA), MHRA (UK), IMB (Ireland), etc
