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V:Kit Software Platform with HPLC Protocols

A comprehensive set of over 50 test templates with SOPs for HPLC/UPLC systems with UV/DAD/PDA, FLD, RID, ELSD and CDD detection.

The test templates are delivered and executed by V:Kit software. Tests can be assembled into user-defined protocols to deliver qualifications on any system configuration.

Default setpoints and limits are supplied and are also user definable within your own customised protocols.

Once authorised, the protocol is secured and version control is enabled.

Standard Operating Procedures

Each test design contains a SOP which is directly accessed from the software. They are centrally distributed and are only accessible by authorised users. Full version control is enabled, and obsolete versions automatically archived, preventing use of out of date procedures.

Each SOP provides instructions on how to execute the test and documents the formulae and calculations used in the data evaluation. This assists the process of data checking by Quality Assurance or external auditors.

Certificates of Analysis

COAs are directly accessed from the software, which automatically extracts and embeds the analytical data directly into the test protocol. This avoids transcription errors and prevents accidental use of out of date materials.

The COA of a batch of a standard used in a OQ/PQ test can be electronically attached to the qualification report. So no more photocopies or poor quality scans….

V:Kit COAs follow ISO guidelines regarding certified values, intended use, homogeneity, storage, hazard and quality information.

Operational Qualification Test Templates

HPLC/UPLC Front End
  • Flow Rate Accuracy/Precision of pumps
  • Gradient Accuracy (quaternary low-pressure and binary high-pressure modes)
  • Temperature Accuracy/Precision (column compartments, sample managers)
UV/DAD/PDA Detection
  • UV Wavelength Accuracy with Holmium Perchlorate (Scan, Injection and Manual modes)
  • Far-UV Wavelength Accuracy with Caffeine (Scan, Injection and Manual modes)
  • Response Linearity
  • Injection Precision with Carryover
  • Injection Linearity
  • Signal-to-Noise
  • Noise and Drift
Fluorescence Detection
  • Excitation Wavelength Accuracy (Scan and Manual modes)
  • Emission Wavelength Accuracy (Scan and Manual modes)
  • Response Linearity
  • Signal-to-Noise
  • Noise and Drift
  • Injection Precision and Carryover
  • Injection Linearity
Refractive Index Detection
  • Response Linearity
  • Signal-to-Noise
  • Noise and Drift
  • Injection Precision and Carryover
  • Injection Linearity
ELS Detection
  • Response Linearity
  • Signal-to-Noise
  • Noise and Drift
  • Injection Precision and Carryover
  • Injection Linearity
Conductivity Detection
  • Response Linearity
  • Signal-to-Noise
  • Noise and Drift
  • Injection Precision and Carryover
  • Injection Linearity

Additional Test Templates (optional)

Installation Qualification
  • HPLC IQ
Performance Qualification
  • HPLC PQ - UV
Planned Maintenance
  • Agilent HPLC PM (1100/1200/1260)
  • Waters Acquity PM
  • Waters Alliance PM

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