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ERP Horror Stories: How a Manufacturer Failed an FDA Audit and Lost $600M in Valuation in a Day

Manufacturers in regulated industries face stringent regulations, with compliance often being a matter of significant consequence. These regulations are not just bureaucratic hurdles; they're designed to ensure safety, quality, and trustworthiness in the products delivered to consumers. Failing to adhere can result in severe financial penalties, reputational damage, and even legal ramifications, emphasizing the critical need for manufacturers to be both informed and diligent in their industry practices.

In this "ERP Horror Story," Microsoft Partners HSO and Merit Solutions discuss the consequences of a manufacturer's decision to implement a generic solution with an ill-equipped partner, rather than choosing an industry-savvy partner with the experience to customize the solution for their specific needs. The company faced a flawed FDA audit, resulting in a staggering $600 million loss in valuation and a 40% decline in stock price overnight.

Key highlights of the discussion will include:

  • How to use your ERP as a way to safeguard your company’s future, regardless of your industry's compliance demands with the FDA, ISO, or others.
  • Tips for selecting the right partner for your D365 deployment or upgrade.
  • Understanding why a generic version of D365 might not meet your needs.
  • The scary consequences of neglecting digital infrastructure.
  • How to avoid costly technological missteps that could severely impact your company.
Bill Burke
Merit Solutions, Inc.
Rick Harper
Area Executive, Regulated Industries
Anya Ciecierski
ERP/CRM Software Blog