The medical device industry must focus on regulatory compliance in order to help patients, burnish the industry, maintain safety, and grow profits. The FDA looms large in all life science industries and has established firm guidelines for compliance.
ERP validation is one of the more challenging steps for your medical device company and is meant to track process stages to ensure quality and compliance. An advanced ERP medical device program simplifies validation and other FDA validation guidance medical devices require. However, your company should create a detailed validation plan to ensure that government regulations are met and correctly reported.
What Is ERP Validation?
The FDA requires medical device manufacturers to validate their process by gathering and evaluating data from all stages of production and implementation of the products. It requires scientific evidence that your company is delivering a quality product that complies with governmental regulations. Since an ERP deals with the process from start to finish, it must be validated as well.
FDA Regulations that Apply to the ERP Validation Process
FDA regulations for this validation process apply to software that is in itself a medical device, software used as medical device components, and software used in medical device production. Any medical device software created after June 1, 1997, must follow certain design provisions. Other important regulations include the following:
Design controls for planning, input, verification, and review are required.
Software automation of any part of the production process or quality system must be validated.
Computer systems “used to create, modify, and maintain electronic records and to manage electronic signatures” must undergo validation.
All production and/or quality system software, including off-the-shelf products, must provide the required documentation. This documentation will define the device’s intended use and provide the data necessary to compare the testing results.
Validating your ERP system requires diligent record-keeping and in-depth documentation of your processes. A problem with your ERP system validation may have costly results, especially if it leads to the withdrawal of FDA approval.
Documentation Required for Regulatory Validation
The FDA requires the following documentation task list for regulatory validation:
- Preliminary Risk Analysis
- Traceability Analysis: Software Requirements to System Requirements (and vice versa)
- Traceability Analysis: Software Requirements to Risk Analysis
- Description of User Characteristics
- Listing of Characteristics and Limitations of Primary and Secondary Memory
- Software Requirements Evaluation
- Software User Interface Requirements Analysis
- System Test Plan Generation
- Acceptance Test Plan Generation
- Ambiguity Review or Analysis
This list requires time and the proper software tools to complete. It is daunting and is just a small part of the FDA requirements for your industry.
Validating Your Medical Device ERP Software
When validating your ERP, your goal is to prove that the software is programmed correctly to follow regulations throughout the product lifecycle. If a problem exists, it may lie in your ERP implementation and not in the software itself. To validate your medical device ERP, you should take the following steps:
- Construct an in-depth plan detailing what you need to accomplish and how you will do so.
- Define the procedures you will use to complete the validation effort.
- Require software validation after any change in your system — even a small adjustment can create unintended, negative consequences.
- Create validation coverage. This coverage is determined by software complexity and safety. Clearly, some devices will require more of an ERP validation effort than others.
- Use independent sources, if possible, to perform the evaluation. If not, create parameters that help eliminate bias.
How Green Business Systems Can Help
Green Business Systems offers NetSuite ERP integrations for Life Sciences. Our expert team can help you customize this software so that the medical device validation process is efficient and accurate.
At GBS, we offer you constant technical support. You can consult with us about any validation difficulty and receive a fast, professional response. We never keep you waiting for a response for more than two hours.
When you are a medical device manufacturer, you need advanced software and a knowledgeable support team to validate your ERP and perform other government-required tasks. We will help you at every stage of this delicate process so that you stay financially healthy and regulation compliant.
For more information about our products and services, request your free consultation by filling out a brief online form or calling one of our skilled representatives. Let GBS guide you through the complexities of ERP validation and other FDA regulatory challenges.