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Situation
A multinational biotechnology company had identified a compliance gap in their product stability testing area. The company was not adequately, nor efficiently conducting Out Of Trend (OOT) analysis on their ongoing stability studies. According to FDA’s Guidance for Industry, OOT results should be limited and scientifically justified. Additionally, as the company has recently merged with another large biotech company, the processes and methods of conducting OOT analysis needed to be harmonized and standardized.
To remedy the situation, the company decided to develop a bespoke Stability Trending Tool that would automate the OOT analysis and then integrate the tool with their LabWare LIMS and ChemLMS legacy systems.
However, before going into production, the new software and its interfaces had to be fully validated and the company lacked the expertise to easily accomplish this.
Read how CSols help their efforts by becoming an extension of the customer’s internal validation team and how we were able to quickly and efficiently understand the new software, provide guidance and direction on the creation of required system documentation, communicate the validation approach, and schedule the needs across the team.
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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.
