Approving WATS for medical production (FDA approval)

The FDA does not currently certify or validate general-purpose software development tools. Medical device manufacturers have the responsibility of validating the software tools they use in the development of a medical device by demonstrating that the tools have an acceptably low risk of harm even in the presence of an incorrect output.

WATS can be validated by medical device companies as part of their regulatory processes. Manufacturers develop and execute plans for validating WATS according to FDA requirements.

Can WATS directly and negatively affect the quality of your products?

Although it’s possible to implement WATS directly in the quality control of your electronics manufacturing, this is not commonly the case. WATS is primarily a tool for analyzing test results with the goal of improving the effectiveness, by continuous improvement, of your production processes. This means that the actual approval of good parts, or disqualification of faulty parts, will be handled by the test equipment software. WATS will only process a copy of the test equipment’s verdicts for analysis.

Provided that WATS is not used for qualification purposes, a wrong output in WATS will potentially cause your team to waste resources investigating false negatives and have a reduced ability to make improvements to your products and processes, but problems related to WATS has little or no direct implication on the quality of approved and shipped products.

Can I FDA approve my WATS Cloud server?

For our standard cloud solution, we have frequent and continuous deployments of hotfixes and new features. This means that unless your validation plan can be fully automated and executed daily, it is not practical to FDA approve the standard cloud solution.

For this purpose, we advise you to use the On Premises version (hosted on your hardware or cloud) where you as the customer are in control if the intervals for updates and validation.

How do you validate WATS?

Validating software involves recording evidence that proves a software system meets the proper specifications and quality attributes. That it’s been installed correctly, and that it will fulfill its intended use.

During this process, you must validate the way you plan to use your software to produce regulated goods and/or perform related business processes. The goal is not only to prove the software will do what you want, but also to identify and mitigate problems that could negatively impact the production of regulated goods or their ingredients.

FDA software validation requirements:

• The products you make and the processes you follow must meet the FDA’s standards for production and inventory management.
• Every step of the validation process must be documented.

The FDA has compiled comprehensive guidance for validation projects, but not all of the recommendations apply to all companies. Validation is based on the degree of risk involved with the product being produced: The greater the risk, the more of the FDA’s guidelines will apply to your validation process, and the more complex that process will be. 

General Principles of Software Validation

How do I create a software tool validation plan?

First you will need to document your plan, by identifying and document the risks, defining contexts of use, and selecting validation activities to reduce risk to an acceptable level. Typical items to document include hazard assessment, tool role in the development process, standard operating procedures, validation approaches, resources, and schedule.

Scope and Objectives:

Define what the software validation plan aims to achieve and its purpose.
Clearly outline the criteria for success and the desired outcomes.

Testing Process:

Create detailed test scenarios and cases based on criteria.
Specify testing methods, environments, schedule, and roles.
Keep records of all validation activities.

Develop a validation protocol.

If the risks warrant testing the output from the tool, create a protocol including test cases, expected results, and assumptions.

Using a predefined and pre-controlled dataset to validate input and output in a system is a fundamental practice in software development and quality assurance. A good starting point for a WATS validation protocol is to establish a control data set, to be used for the validation process.

The validation process would start by submitting your pre controlled dataset to the WATS server and then performing the different validation processes, either automated, by controlling different calculations using our API’s, or manually by using the Web Application and analytics features to reproduce reports and validate outcomes.

Execute the validation protocol.

The execution of the validation protocol is typically done at every update to the software, and/or at desired intervals. The complexity and duration of this process depends on your risk assessment and the protocol itself, but to avoid the services being offline in the validation process a setup with two servers is advised.

This lets you operate on a production server, while the redundant server is updated and validated. Once the validation process is completed and approved a DNS-switch is performed to replace the production severs with the newly approved ones.

The process can then be repeated when needed.