The program offers researchers automated lab instrumentation qualification which aims to ensure equipment works at optimal capacity, as well as remaining regulatory compliant.
The firm claims the new service, developed for use in the pharmaceutical, biotech and other regulated companies, can handle any lab which falls under GLP/GMP or ISO17025 regulations.
Dusty Tenney, president of PerkinElmer's Analytical Sciences and Laboratory Services business, told in-PharmaTechnologist: “All labs in a regulated environment must perform annual qualifications on their critical analytical instruments.
“In addition to meeting specific regulatory requirements, companies are continuously looking for ways to improve their productivity, drive cost reductions and minimize risk.
“To help achieve this objective, the UOQ delivers a solution that maximizes instrument uptime through qualification protocol optimization; harmonizes reports to streamline the qualification process; and provides automation to minimize calculation and transcription errors.”
Slick operation
Through its UOQ, PerkinElmer claims it can streamline the qualification process for all lab instrumentation, as well as providing the capability to harmonize documentation across all major models of laboratory instruments with uniform testing, regardless of manufacturer.
“The UOQ was designed to minimize the time required in each step of the qualification process,” said Tenney.
The procedure includes a “simple and fast” review protocol with set-points and limits which are transcribed into the Report Engine using an automated process. The validated Report Engine then performs all calculations, determining a pass or fail.
Finally, PekinElmer claims that the time taken to the review and approve the final report is reduced by delivering only the results for the modules of the instrument tested with both overall and summary results.
Demand
Tenney also anticipates significant demand for the service, given the drug industry’s need to reduce costs, maximize efficiency and find third party providers for non-core skills.
“PerkinElmer provides qualification expertise by bringing an unsurpassed level of understanding for all regulatory requirements around instrument qualification.”
He added: “More and more customers look to outsourcing non-value added services in order to focus on science and throughput.”