What is ERP Validation

Enterprise Resource Planning (ERP) validation is a critical step for FDA-regulated industries, to ensure compliance with regulatory requirements and industry standards. This process ensures that the ERP system accurately and consistently tracks and records critical data, such as product information and manufacturing processes. In this blog post, we will discuss why it is necessary to validate your ERP, when you should validate it, the consequences of not validating, and why you should partner with Performance Validation for your ERP needs. 

Why Do I Need to Validate My ERP? 

ERP validation is required for organizations in FDA-regulated pharmaceutical and medical device industries, depending on the regulatory impact of the system.  Regulatory agencies require validation to ensure that the ERP system meets requirements and industry standards, and that it accurately reflects the manufacturer’s intended use. For example, in the medical device industry – 21 CFR Part 820.75 drives the need for ERP validation. For many companies, the regulatory impacts of an ERP include product traceability, manufacturing functions, and bill-of-material functions. By validating the ERP system, manufacturers can guarantee that the data it contains is trustworthy and reliable, and producing safe and effective products. 

When Do I Need to Validate My ERP? 

ERP systems must be validated prior to production use. Specifically, functions of the system that impact the Quality System and/or product quality, efficacy, and/or patient safety must be validated.  

Manufacturers must maintain the validated state of the ERP throughout its lifecycle. This may include whenever operational and/or software changes are made ERP system itself. Examples include upgrades, bug fixes/enhancements, customizations, and the implementation of new business processes. The validated state of the system should also be periodically assessed to ensure that the ERP system continues to meet regulatory requirements and industry standards. 

What if I Don’t Validate My ERP? 

If a manufacturer does not validate its ERP system, they run the risk of being out of compliance with regulatory requirements and industry standards. This could result in costly regulatory penalties, including fines, product recalls, and even legal action. In addition, an unvalidated ERP system may contain unreliable data, which could impact the quality and safety of the manufacturer’s products. 

Why Should I Choose Performance Validation to Validate My ERP? 

By partnering with Performance Validation, you will benefit from our team’s extensive knowledge of the intricacies of ERP systems and the regulations and standards that must be met. This knowledge, combined with our experience with a wide variety of ERP systems, enables us to streamline the validation process faster and accurately, resulting in a smooth and seamless implementation for our clients. 

In conclusion, ERP validation is an important step for organizations in regulated industries to maintain compliance, and to ensure product quality. Our deep understanding of ERP system complexities and extensive experience sets us apart and allows us to deliver high-quality, cost-effective validation services to our clients. If you need ERP validation services, please schedule a call with our subject matter expert, to learn more about how we can help. 


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