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ERP Horror Stories: A Manufacturer's Failed FDA Audit

by MSDW Reporter
Editorial Team, MSDynamicsWorld.com

UPDATE: The recording for the webcast describe in this article is available here.

Plenty of horror stories about failed ERP implementations swirl around the IT ecosystem. And there are probably many more that customers and implementation partners would like never to discuss again. Failed implementations can be costly in terms of time, resources, future possibilities, and even reputations. But there is a greater consequence that you'll want to consider.

For manufacturers in regulated industries, compliance is a matter of significant consequence. Governmental and industry regulations are not just an excuse for more paperwork and red tape. They are set in place to ensure safety, quality, and reliability in the products delivered to consumers. These regulations can actually save lives.

Failing to adhere to such regulations could result in hefty financial penalties, a damaged reputation, and even legal actions. Clearly, this highlights the need for manufacturers to be informed about their industry regulations and be diligent in their adherence. It's also essential to work with a technology partner that understands the ins and outs of your industry and its specific regulations.

An ERP implementation horror story

An "ERP Horror Story," told to us by Microsoft partners HSO and Merit Solutions concerns a manufacturer with an ERP solution that wasn't adequately tailored to their industry. The company faced an FDA regulatory audit, and when they failed it led to negative consequences resulting in a staggering $600 million loss in valuation and a 40% decline in its stock price overnight.

On Wednesday, October 4, Anya Ciecierski, co-founder of the ERP Software Blog, will interview Rick Harper of HSO and Bill Burke of Merit Solutions. Tune in at one of the times listed below and hear their take on the ramifications of an ERP implementation gone wrong and how to avoid the same problems.

Highlights of the Interview

Key highlights of the discussion will include:

  • How to use your ERP to safeguard your business, regardless of your industry's compliance demands with the FDA, ISO, and others.
  • Tips for selecting the best Microsoft Dynamics partner for your D365 implementation or upgrade.
  • Understanding why a generic version of D365 might not meet your needs.
  • The far-reaching consequences of neglecting digital infrastructure
  • How to avoid costly technology mistakes that could severely impact your company.

Presenters:

Moderator:

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

  • Wednesday, October 4, 2023 - 9 am, 12 pm, 3 pm EDT
  • REGISTER NOW

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Claudio
Submitted by Claudio Valtorta on Mon, 10/09/2023 - 08:00 Permalink

The standard QC functionalities in F&O are too basic, MS should work in impolementing  some new procedures if they want to be really competitive.

Alexandra
Submitted by Alexandra Campbell on Fri, 02/23/2024 - 09:00 Permalink

Failure to uphold these regulations can lead to severe penalties, reputational damage, and legal repercussions. This underscores the critical necessity for manufacturers to fully grasp their industry's regulatory landscape and meticulously adhere to its requirements. Equally crucial is partnering with a technology provider well-versed in the intricacies of the industry and its specific regulatory demands. Additionally, it's imperative to craft a compelling motivation letter explaining the need for such a partnership, as well as considering the option to buy motivation letter if necessary.