Consolidated Qualification Solution to Ensure Laboratory Compliance

PerkinElmer’s OneSource® Laboratory Services has demonstrated how its multi-vendor and audit proven IQ OQ PQ solution can reduce the compliance burden. The proprietary LabMetrix offering, powered by 21 CFR part 11 validated software, features digital data collection, automated report generation and patented validation test hardware calibrated to ISO 17025 standards. By employing LabMetrix technology, OneSource consolidates equipment qualification for all instrument platforms. This advanced, fifth generation, metrology-based approach provides harmonised qualification documentation across multiple vendors and technologies and is available worldwide.

OneSource allows the benefits of a single validation master plan to be realised with one solution for all laboratory instrument qualification, ranging from general equipment (such as refrigerators, freezers, balances and dissolution technology) to multi-component hyphenated analytical instrumentation (such as LC/MS/MS). IQ OQ PQ protocols are continually updated in accordance with changes in Pharmacopeia regulations to reduce the risk of non-compliance, with the flexible LabMetrix software allowing custom qualification protocols to be designed. Real-time data is backed up electronically and results are consolidated into a single, standardised auditor-friendly report to provide a fully traceable audit trail and comprehensive metrology aligned reports.

With a multi-vendor services portfolio developed over 10 years and spanning laboratory relocation, managed maintenance and asset management, the OneSource team will be on hand to explain how consolidating laboratory services and adopting an integrated approach reduces overall costs, equipment downtime and improves laboratory productivity.