Challenge
Celera Diagnostics needed to move from a non-FDA regulated environment to one that would meet FDA requirements and be scalable to support burgeoning sales from a successful alliance partner program.

Solution
Invested in an ERP system to support the business, with special consideration given to 21 CFR Part 11 to ensure that electronic records were in compliance with FDA regulations.

Benefits
During the implementation, Celera Diagnostics received FDA approval to market one of its diagnostic products; within just a few months, sales volume increased 20-fold. The business is no longer constrained by internal systems, and is poised with the infrastructure to experience additional high growth.

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