Documentation with V:Kit 5

Efficient, reliable, and secure documentation and reporting is fundamental to the integrity of the qualification process.

V:Kit 5 reports are an integral part of the system. You gain immediate access to documents for performance, traceability and quality control, such as:

  • Standard operating procedures
  • Certificates of analysis
  • Certificates of calibration for tools

Repro of standard operating procedure for hplc flow rate to illustrate article on v kit 5 documentationRepro of v kit 5 qualification report for illustration onlyrepro of v kit 5 audit trail certificate for illustration onlyRepro of v kit 5 certificate of analysis for illustration only

Standard Operating Procedures

V:Kit is supplied with one or more SOPs detailing the qualification procedure. SOPs show the calculations used – allowing auditors to quickly verify the integrity of reports.

Change control information is also included, highlighting any changes since a previous revision.

The correct SOP is accessed directly from the relevant screen in the V:Kit 5 program.

Qualification Report

A qualification report can be printed many times, and can be access from your V:Kit database. However a test can never be re-processed.

Each qualification protocol may consist of individual tests. For example a detector may need qualifying for response linearity, signal-to-noise, and wavelength accuracy. Each test has an SOP, a certificate of analysis or calibration, raw data, and a test certificate.

Failure action and deviation reporting

The possible outcomes of individual tests in a qualification are 'PASS', 'FAIL', or 'SKIP'. If any result other than PASS is reported, the reasons must be recorded as a deviation.

The audit trail – which includes these deviations, and provides a detailed history of the qualification – is maintained during the running of the protocol and is available for reporting when the protocol is complete.

V:Kit 5 Modes Comparison

link to page showing V:Kit 5 modes comparison tables

More about V:Kit applications

green panel illustrating hplc technique capability of v kit 5, click for more information on using v kit for hplc qualification
green panel illustrating v kit for gc and gcms qualification, click for more information
green panel illustrating v kit for tablet dissolution qualification, click for more information
green panel illustrating v kit for u v vis qualification, click for more information
green panel illustrating the fact of using v kit 5 for analytical balance qualification, click for more information

S5 Box