The Dangers of Playing Catch-up in the World of FDA Validation
The validation process typically starts when a medical device organization documents the requirements to select ERP software. Requirements definition is also the first opportunity for a company to have a validation conversation. However, most companies have the validation requirements conversation after they select software, only to later realize that they may have purchased software that is difficult to validate with the FDA. As a result, the implementation can take longer than initially expected and the risk of unexpected and costly FDA Validation remedies are introduced. Therefore, it is vital for all medical device manufacturers to include their specific validation requirements in any software selection process, ERP or ancillary. Otherwise, you will join many other manufacturers in the difficult game of ‘catch-up’ in the FDA validation world.
The key during this process is making the right-sized plan for validation. Not sure if your FDA validation plan is the right size for your business? Read on.
FDA Software Validation: What is Required?
The FDA requires that software used for the design, manufacture, packaging, labeling, storage, installation, and servicing of all medical devices intended for human use must be validated. This validation process is made to ensure that the product created by the manufacturer meets the needs of the user.
Required Documents for Software Validation
There are numerous documents that are often vital for software system verification and validation. Here are a few.
- Software Validation Protocol (Validation Plan)
- The validation plan reports the project deliverables and responsibilities.
- Requirements Traceability Matrix
- This lists all the system requirements, and it links the test case IDs with the requirements ID.
- Risk Analysis
- The risk analysis will evaluate potential risks and how they affect application safety. As we will discuss, this assessment primarily focuses on common business processes.
- Final Validation Report
- This document includes information such as a summary of the validation documentation and test case results, hardware and software descriptions, dependencies, a summary of all the validation activities, and the work instructions required to train users to use the system.
Note that companies cannot simply purchase the required validation documentation. The FDA requires that validation activities cover how a system is configured in the user’s environment, so the solution will be unique to each company.
The Dangers of Playing Catch-Up
If a medical device manufacturer takes into consideration software validation after selecting software, instead of before, the company may find itself with niche or highly customized software. This can lead to difficulties during validation because the functionality is not well-known, and determining the risk associated with the software can become a lengthy process, causing the company to play “catch-up” with validation.
This catch-up in the world of validation can result in the consumption of weeks or even months of valuable time and effort. Hindrances in the validation process can lead to delays in launching new software, which can lead to its own risks for the company. Out-of-date software can lead to cybersecurity risks, and it can further slow the company down because business processes are no longer optimized.
To sidestep the issues described above, companies should leverage software that has a proven track record with FDA validation, thereby minimizing the costs associated with the validation process.
The Right-sized Validation Plan for Your Business
The FDA requirements listed in 21 CFR Part 11 don’t give much specific direction for electronic system validation. This causes many companies to validate more than what is needed—therefore, their validation plan is not rightsized for the business. To decrease the time spent conducting validation, companies should use a risk-based approach by performing risk assessment, especially on the critical business processes (CBPs).
One best practice approach outlines three categories of validations according to the level of risk of the CBP—either high, medium, or low, and the amount of testing required depends on the risk level. For example, high risk involves complete, comprehensive testing, while low risk involves no formal testing.
Often, companies who are trying to validate more than necessary are treating the “high” category as the traditional method of validation. This practice can greatly increase the amount of time spent on validation.
To further assist in rightsizing a validation plan, companies should seek to engage an FDA validation expert or partner that has experience performing validations across multiple businesses.
How QAD Can Help
The QAD ERP application is one such software that can reduce the amount of time and effort required for companies to conduct software validation and establish 21 CFR Part 11 compliance. Companies looking to select software with a proven track record with the FDA should note that QAD has been a solution partner in the medical device industry for decades. Furthermore, the QAD ERP application supports FDA QSR, ISO 13485, and EU MDR requirements.
QAD’s ERP application suite includes numerous features to satisfy compliance requirements. These include:
- Compliance module
- Forward and backward traceability
- Enterprise Asset Management (EAM) for CFR Part 820 and ISO 12485 compliance
- Product Change Control module for 21 CFR Part 11 compliance
- SOX Change Control Requirements
- SDLC and Workflow for change management
FDA validation is just one aspect of running a successful and lawful medical device organization. Logan Consulting is a firm that has helped transform numerous medical device organizations in all different aspects of their business. To learn how they can transform your organization, please click here.
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