Regulatory compliance and multi-vendor IQ OQ PQ for the entire laboratory
OneSource Laboratory Services is the only service provider that offers a complete library of IQ OQ PQ protocols covering all laboratory technologies and equipment manufacturers worldwide. Our global team of laboratory compliance experts help companies assess, develop and implement cost effective and highly efficient regulatory compliance programs.
- 20 years of experience developing and delivering multi-vendor qualification services
- More than 100,000 instrument qualification completed
- 0 failed audits or warnings
OneSource designs compliance protocols, qualifies, calibrates, validates, and fulfills the documentation requirements for:
Any instrument or laboratory equipment:
| Technologies we service |
| Chromatographs | Incubators |
| MS | Refrigerators/Freezers |
| FTIR | Plate Readers |
| AA | Dissolution systems |
| ICP | Liquid handling |
| And many more... |
Any manufacturer:
| Manufacturers we service |
| PerkinElmer | Agilent |
| Waters | Thermo |
| GE | Dionex |
| Shimadzu | Beckman-Coulter |
| Applied Biosystems | Varian |
| And many more... |
A complete portfolio of multi-vendor IQ OQ PQ servicesWith more than 20 years of experience and over 100,000 qualifications successfully completed, we offer multiple approaches to equipment validation / qualification to ensure that our compliance services are perfectly aligned with each customer’s needs:
- Classic Qualification offers traditional application-based methodologies.
- LabMetrix® Qualification applies an audit-proven, 100% harmonized metrology-based solution.
- System Life Cycle Validation offers Computer System Validation in conjunction with IQ OQ PQ
- Manpower OnDemand provides experienced OneSource compliance engineers to perform qualification and other compliance activities
OneSource, your partner for cost-effective and highly efficient regulatory compliance
Our experience and perspective enable us to offer you real value in helping you assess, develop, and implement regulatory compliance at the level you need.
We offer:
- Custom Validation Master Plan (VMP) development
- Preparation of multi-vendor IQ OQ PQ protocols - tailored to specific laboratory requirements.
- Complete qualification services performed at the component, instrument, and system level - including for mixed systems such as LC/MS from multiple manufacturers
- A single, holistic compliance plan for all of the equipment in your laboratory
- Creation of remedial/corrective action plans (system failures and 483 responses).
- Execution of change control, and SOPs as well as validation protocols.
- Performance verification (PV) of laboratory equipment for routine R&D, QA/QC, EPA, FDA, and client-compliance operation.
- Review of QA/QC audits.