OQ Documentation made easy

Qualification Reports -Consistent and Clearly Formatted

Qualification reports are created via an onboard pdf creator and can be printed many times. They can be viewed again directly from the v-kit Pro database, however the test can never be reprocessed, therefore complying with 21 CFR part 11.  With v-kit Pro Summary Report tool the OQ reports can be compiled along with a concise Qualification Summary document, Audit Trail, Protocol, and other user documents such as Training Records and Chromatography Report. This produces a fully paginated, password secured PDF document ready for review and sign off. 

Qualification Protocol -Controlled and Secured

Each qualification protocol may consist of several individual tests — for example a gradient HPLC system would require tests for pump flow rate accuracy, gradient accuracy, temperature accuracy, detector response linearity and signal-to-noise, plus autosampler precision. These tests should be documented in advance and the setpoints and criteria defined. This is your Qualification Protocol and v-kit Pro contains the Protocol Manager tool to make this process simple and secure.

Writing and maintaining SOPs is time-consuming, but v-kit adds significantly to the speed and efficiency of the process.

Each v-kit is supplied with SOPs detailing the qualification procedure. These include the calculations used to allow auditors to quickly verify the integrity of the reports. Change Control information is also included, highlighting the changes since the previous revision. The correct SOP is accessed directly from the relevant screen in the user interface, and can be incorporated into the qualification logbook at the click of a button.

Traceability Information - readily accessible 

Certificates of Analysis and of Calibration are at your fingertips in v-kit. They can be viewed immediately and printed at any time. v-kit Pro allows the certificates to be compiled into the overall qualification binder to demonstrate standard and tool traceability.

 

photo of HPLC v-kit reference standards
HPLC V:KIT protocols include:

  • Pump flow rate accuracy and precision
  • Gradient composition accuracy and linearity
  • UV/Vis, PDA/DAD and fluorescence detector wavelength accuracy
  • UV/Vis, PDA/DAD, fluorescence, refractive index and ELS and conductivity response linearity
  • Autosampler injection volume precision and carry-over
  • Autosampler injection volume linearity
  • Column oven and autosampler tray temperature accuracy

photo for v-kit lcms qualification
LCMS V:KIT protocols include:

  • Mass Accuracy test
  • Signal to noise test
  • Pump Flowrate and Gradient proportioning test
  • Autosampler Precision, linearity & carryover test
  • Temperature Accuracy and Stability for Column and Sample Compartments

v-kit gcms protocols image
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

v-kit GC protocols
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)

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