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Software is a significant investment, whether you are coding your own, purchasing for in-house installation, or accessing it on line. This is especially true for FDA regulated companies, because you need to meet compliance requirements for the software that tracks these activities. This must be balanced against the risks of not having software. The tracking method a company uses for these operations is part and parcel of the overall strategy for compliance. As companies grow, they balance the risks of staying with non-qualified systems against the risk of non-compliance.

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