Taking Control of Analytical Validation

Aitken Scientific has successfully produced specialist software for NLG Analytical’s v:kit™ series of fully traceable and 21 CFR Part 11 compliant validation kits for HPLC and GC in analytical laboratories.

NLG’s Business Development Manager Stephen Luke explained, “Aitken Scientific were selected for this project due to their experience in developing software for laboratory use, in our case with chromatography systems, and their expertise in programming for 21 CFR Part 11 compliance.” The v:kit provides a cost-effective and timesaving solution for the operational and performance qualification (OQ/PQ) of HPLC and GC instrumentation—key to maintaining regulatory compliance in analytical laboratories. Each kit contains the standard operating procedures, documentation, materials and bespoke software required for data analyses to produce traceable results against user defined pass/fail criteria.

Aitken Scientific adhere to Good Automated Manufacturing Practice (GAMP) guidelines for computer system validation and offer a high quality software development service for companies of all sizes. Having developed the robust v:kit software, they have been able to supply immediate technical support and seamlessly maintain contact with NLG’s customers as and when required, regardless of their locality.