Costs Abound with Regulatory Noncompliance: Lessons Learned on ERP Implementation

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Over the past several years, the pharmaceutical industry has plunged headfirst into ERP systems implementation. This broad-based effort motivated by Y2K and aging legacy systems created an opportunity for our business to execute several large-scale GMP system projects. All the efforts achieved some level of success; however, all suffered avoidable setbacks. In addition, the ERP vendors always assume that all the solutions lie within their "license." This is a dangerous assumption, in that lower cost GMP compliant solutions exist readily. The purpose of this paper is to discuss several projects in the context of "lessons learned" in an effort to provide guidance for future efforts. The paper will focus on: 1. Development time and control of costs 2. Regulatory compliance and the cost of noncompliance 3. The use of prepackaged systems to offset ERP development expense © 2000-2001 World Batch Forum. All rights reserved. Page 2 4. Functionality (i.e., given time and money, anything can be built) 5. Testing and validation – why they never get together 6. Validation and why it is still a problem 7. Documentation – why it is always created late and wrong 8. Methodologies – are great in sales presentation The paper and its presentation will be a lively but brutally honest discussion of ERP implementations. This paper is geared for IT, QA, and manufacturing professionals involved with or planning to implement an ERP or manufacturing system project in a GMP environment.