OneSource provides a comprehensive range of compliance and validation services as a standalone service or as part of a OneSource Triage, Managed Maintenance, Multi-vendor Maintenance or Relocation solution.
Multi-vendor Qualification Program
The OneSource multi vendor qualification program provides IQ/OQ, OQ and PQ services for all the equipment in your laboratory and process areas including LC, MS, Dissolution apparatus, Incubators, Fridges/Freezers, Balances, Autoclaves, Mixers, and Blenders etc. Our library of protocols is huge and we have the compliance and scientific knowledge to qualify all of your equipment, even if the original manufacturer does not have a protocol. Qualified personnel can design your complete validation master plan, tailor multi-vendor qualification protocols to your exact requirements, supply skilled labor to execute existing protocols against a schedule or provide support for your entire compliance process.
Choose a OneSource qualification program to:
- Fully support your internal SOPs and QA procedures
- Achieve a consistent and standardized documentation format for all equipment that simplifies the review and control process
- Remove the variability in testing methods and tolerances found in different OEM protocols of the same technology by consolidating into a single document
- Speed qualification by adopting a holistic system level approach to low risk systems
- Control the quality of people performing your qualifications
- Streamline the length protocols take to execute to minimize equipment downtime
- Ensure hyphenated or mixed component systems such as LC-MS are qualified as a system
- Fill gaps where there is currently no approved protocol
- Make your process more efficient and therefore more cost effective
- Put in place an independent review of the PM and Repair performance of your service providers
System Life Cycle Validation
The OneSource system life cycle validation program integrates Computer System Validation (CSV) with Design, Installation, Operational and Performance Qualification to provide a comprehensive validation study for GxP laboratories. The service can be expanded to include SOP creation and training for users and method transfer validation studies. The service is currently provided for IR, HPLC, UPLC and CDS technologies from the majority of manufacturers, and includes provision of qualified personnel, document preparation and control, traceability matrices, completion of documents and summary report.
Choose a OneSource System Life Cycle Validation service to
- Gain access to technical resources you don’t have or don’t have enough of
- Rapidly get systems validated and operational
- Validate and qualify equipment to the standards demanded by your QA process
- Avoid spending capital on new equipment and then not realizing a Return on Investment (ROI)
Combine multi-vendor qualification and validation services with OneSource multi-vendor maintenance and or asset management solution and or relocation services to maximize the efficiency of your lab.