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Situation
A contract pharmaceutical testing lab had received citations from Health Canada regarding the data integrity of their Waters Empower™ 2 CDS.
While conducting a site visit, Health Canada found individual Empower 2 workstations operating with limited control over roles and their system access, which raised data integrity concerns around the data that they were generating.
The client tried to initiate their own short-term solutions for the data integrity issues, but they learned that their solutions may become unmanageable as the data grows in volume – creating more problems down the road.
Health Canada gave them 90 days to resolve their noncompliance. CSols, Inc. was selected to assess the Waters Empower CDS workstations.
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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.”
“This is the dream team. I wish I could work with you on all my projects. Thank you for the wonderful work!”
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.
