The most comprehensive analytical instrument qualification solution in the industry
The LabMetrix Qualification Solution available exclusively from OneSource, is a complete compliance system that uses proprietary protocols, patented hardware, software, and expert resources to deliver a single analytical instrument qualification solution for the entire laboratory - regardless of technology or manufacturer.
Benefits to your laboratory:
- Reduced risk of non-compliance using a metrology based approach to qualification.
- Easier audits from our succinct, consistent, and easy to review audit reports
- Audit-readiness with a single, fully integrated approach to document management applied across the entire laboratory
- Control costs by working with one provider to leverage economies of scale through qualification-service consolidation and harmonization.
- Improve productivity by consolidating qualification services with one provider familiar with your specific needs.
Our audit proven solution consists of 6 steps, anchored by exclusive technology, to make maintaining compliance easier and more cost effective.
The LabMetrix System
Before Qualification
- Capture user requirements - careful monitoring of changing regulatory requirements (USP, FDA, AIQ, etc.) and partnering with laboratory managers to understand application specific compliance needs.
- Validation Master Plan (VMP) - OneSource compliance experts work with customers to develop a single VMP to govern all qualification activities - including change management and integration into existing quality systems. Unique to our offering, the VMP is available as both a printed document and a 21 CFR part 11 compliant digital record.
During Qualification
- Perform qualification - expert resources use the patented 6th generation LabMetrix platform, ISO 17025-calibrated (to NIST and COFRAC standards) hardware along with associated software to perform semi-automated multi-vendor instrument qualification.
- Harmonized reports - streamlined compliance reports for all manufacturers and instrument technologies.
After Qualification
- 100% compliance - clear, concise, easy to read printed audit reports with secure digital archiving in a 21 CFR technically compliant environment.
- Audit ready - on-demand generation of all compliance data - including training and calibration records.
This metrology-based solution is ideal for medium to large labs that are looking to streamline and harmonize their compliance requirements. Our LabMetrix solution can significantly reduce the cost, risk and time required to maintain compliance across a broad range of laboratory equipment.
Summary of key features of the LabMetrix Qualification Solution:
- Integrated solution anchored by patented GLP100 hardware technology and propriety 21 CFR part 11 technically compliant software
- Automatic and secure digital archiving of all compliance data and related records
- Protocols that are continually aligned to changing regulatory requirements for minimum compliance risk.
- Qualification for the entire operational range, even if the requirements differ from system to system.
- Fully scalable solution delivered by certified engineers with protocols for all laboratory technologies and equipment manufacturers.
- Harmonized VMP makes qualification consistent across your entire enterprise and facilitates change management.
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