OneSource's in-depth expertise in equipment qualification / validation goes beyond implementation of protocols. OneSource also designs customized protocols.
OneSource compliance experts write multivendor IQ OQ PQ protocols to address a variety of client needs, including:
- Unification and harmonization of protocols across an entire laboratory operation - across all systems and all manufacturers.
- Qualification protocols and documentation t harmonized with internal QA/QC standards.
- IQ OQ PQ protocols for any instrument that lacks qualification procedures.
- Protocols for unique "mixed" systems: systems including components from multiple manufacturers.
- Laboratory systems with specialized configurations or specialized processes.
- Unique one-of-a-kind instruments.
OneSource develops equipment qualification protocols for instruments from virtually every manufacturer, including unique configurations from manufacturers such as:
- Agilent
- ThermoFisher
- Waters
- Shimadzu
- ABI Sciex
Unlike protocols from instrument manufacturers, OneSource protocols are customized to meet specific client requirements, and employ a uniform format from instrument to instrument. Uniformity simplifies document reviews and audits.
Examples of custom equipment qualification/validation protocols
| LC/MS |
LC/MS with HPLC front-end from one vendor and back-end Mass Spectrometer from a different vendor. Examples:
- Agilent HPLC with Waters, Thermo (Finnigan), or Sciex API Mass Spectrometers
- Shimadzu, PerkinElmer, and Waters HPLC with Sciex API or Thermo (Finnigan) Mass Spectrometers
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| GC and GC/MS |
GC and GC/MS with GC front-end from one vendor, and other accessories, such as sample introduction units, from another vendor. Examples:
- GC Headspace System with HP/Agilent GC or GC/MS and headspace sampler from PerkinElmer or Teledyne Tekmar
- GC Purge and Trap System with GC or GC/MS from HP/Agilent, PerkinElmer, Varian, or Shimadzu, and with Purge and Trap sample introduction from Teledyne Tekmar or O.I Analytical
|
| HPLC or LC/MS with third party Autosamplers |
- Examples include an HPLC from HP/Agilent, PerkinElmer, Shimadzu and an Autosampler from CTC Analytical (LEAP) or GERSTEL.
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| GC or GC/MS with third party Autosamplers |
- Examples include an GC from HP/Agilent, PerkinElmer, Shimadzu, Varian and an Autosampler from CTC Analytical (LEAP) or GERSTEL
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| HPLC systems |
HPLC systems with degasser, column compartments, pumps, detectors, and autosamplers from various manufacturers, including HP/Agilent, PerkinElmer, Varian HPLC systems. Examples:
- RI detector from Shimadzu
- Additional detectors such as ELSD (evaporative light scattering detector) from Polymer Technology, SEDEX or Alltech Associates
- Flow Scintillation Analyzer from PerkinElmer.
- Charged Aerosol Detector, Corona from ESA
- Electrochemical Detector from ESA
- Other mixed systems with components from various manufacturers
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Expert resources, where and when you need them
OneSource is the only major instrument service provider with on-staff engineers trained on a broad range of scientific instruments across the full range of manufacturers.
We leverage our unique training investments and robust processes to regularly augment the skills and experience of the industry''s best people, OneSource Service Engineers, to help labs of all sizes maximize scientific, operational and financial efficiencies regardless of equipment types or manufacturers.