Validation of Thermo
Scientific SampleManager
LIMS™
Case Study Request
Situation
A Specialty Chemical Company providing precursors and additives for cosmetics and other beauty products was managing their testing lab utilizing SampleManager LIMS™.
Unfortunately, the organization neglected to fully document and validate their LIMS and when audited by the FDA, received a warning letter.
In order to re-attain and maintain regulatory compliance, the company turned to CSols to assist with their computer systems validation efforts.
In this case study, you'll read how CSols was able to use their SampleManager LIMS expertise, Computer Systems Validation (CSV) and Regulatory expertise, and their outstanding domain knowledge (specialty chemical quality testing labs) to help the client become compliant and pass the FDA inspection.
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“Thank you for all the hard work to get this done!! You communicated clearly and concisely via email and kept the project moving; it all went extremely smoothly. The project was completed ahead of schedule and on budget, so can’t ask for any better outcome. You did a great job.”
Solid waste disposal company, LIMS upgrades, LabWare
“This is the dream team. I wish I could work with you on all my projects. Thank you for the wonderful work!”
Cleaning products manufacturer, Configuration, STARLIMS
First, I wanted to let you know that we were very impressed with our time with you last week. We thought the process was good and believe the As-Is and To-Be diagrams appropriately reflect our current and future environment.
Specialty chemicals company, OCM for LIMS implementation, LabVantage