V:kit validation kits
Authorities such as the FDA and MCA require laboratories to calibrate their instruments on a regular basis.
Developing your own test protocol is very time-consuming and there is always a concern that it does not fully comply with current standards. With V:kits from NLG Analytical your laboratory will benefit from the audits and procedures that have been used within the pharmaceutical industry for many years. V:kit minimizes your compliance risk and reduces compliance costs.
The kits allow you to perform OQ/PQ tests on your own analytical instruments. Each kit consists of the procedures, documentation and material required to perform the OQ/PQ tests or various instruments.
Regardless of whether you perform regular validation checks, tests before or after maintenance, or after replacing components or moving an instrument, v:kit provides you with a cost-effective and credible regulatory backorder for all your analytical systems.
Fully traceable and 21 CFR Part 11 Compliance kits are available for HPLC and GC. Traceable means that measurements can be traced back to national and international standards, such as NAMAS (National Accreditation of Measurement and Sampling).
V:kits validates the following types of instruments
HPLC systems: Isocratic and gradient pumps, UV/Vis detectors (including PDAs), fluorescence detectors, refraction index detecotrs, column thermostats and Autosamplers.
GC systems: including automotive injectors, Headspace Samplers, FIDs ECDs and TCDs.
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