For U.S. Food and Drug Administration (FDA) regulated industries, software validation is required to ensure that the operation of software will consistently produce results meeting predetermined specifications. Additionally, software validation is a good business practice for organizations that want to improve GxP (good practice) procedures and documentation.

What is software validation?

Basically, it is a technical documentation process that FDA compliant and high standard GxP organization use to ensure that software systems (eg. Enterprise Resource Planning (ERP) solutions) fulfill their intended purpose. Stringent quality control requirements in FDA regulated industries increase the need for specific controls and procedures to be followed. Evidence that these controls and procedures have been followed and that they have resulted in a sound system which satisfies its requirements must be documented. The process of applying the appropriate controls and procedures and creating the necessary trail of documented evidence are all part of validating a software system.

Who needs to be validated?

Manufacturers who must meet and maintain FDA compliance, including but not limited to: pharmaceuticals, companies that supply into the pharmaceutical industry, botanicals, surgical instruments, medical devices, prosthetics, dental equipment and related supplies, orthopedics, medicinal, ophthalmic supplies, and diagnostic substances. Additionally, any organization who is interested in creating and maintaining a high standard of GxP procedures can also benefit from completing a software validation.

Why do it?

Software validation may seem an overwhelming task especially for small to mid-sized companies. However the benefits of validating prove to be well worth the cost. Some of the reasons why businesses should consider software validation include:

• Saving money by discovering weakness or flaws in one’s processes prior to production;
• Providing management with a clear understanding of risks so that appropriate decisions can be made;
• Increasing the likelihood projects will be completed on time and within budget;
• Increase product and system quality;
• Meeting regulatory compliance.

How to approach software validation?

Before commencing a software validation, it is essential that a software validation plan is put into place to save time and money and make the undertaking manageable. It is important to find a validation team that has the time and decision making authority to follow through each of the following phases below:

• Installation Report: This document serves as evidence that the software was installed correctly according to the vendor recommendations and design. If your vendor performed the installation, you should get the information from them.

• Testing Protocol: The document outlines the specific objectives, procedures, data sets, test scenarios, expected results, and acceptance criteria for the system testing process. These protocols should test the software components your company will utilize. It is not necessary to test every setting available. The software vendor should have tested the various setting combinations. The testing protocol should simply include evidence that a test was performed. Evidence might include screen shots and report print outs documenting the projected results. This information will be used to generate the testing report.

• Testing Report: This document outlines the testing that occurred. Typically, it will include an executive summary of the test execution that addresses adherence to test procedures, acceptability of results, as well as any unexpected results.

• System Release / Go-Live: The system release allows the software to be used in production. By this time, the users have been trained, data has been entered, and business scenarios have been completed. The users can now begin using the software.

• Complete Validation: Once the validation is complete, the system must be maintained in a validated state. Maintaining this state required that standard operating procedures are in place for addressing problematic concerns and resolution, change control, record retirement, etc. If changes are required within the system, the changes should be reviewed and assessed for risk. Necessary changes should be authorized, documented, tested and approved before implementation occurs.

Conclusion

Software validation does not have to be an overwhelming task when approached in an organized manner. By preparing a plan and following through each step of the way, software validation is manageable. Feel free to contact us at 973-822-1551 for more information about creating a software validation plan for your business.

Datacor, Inc. understands the unique challenges that FDA compliant manufacturers and other businesses trying to maintain a high standard of GxP procedures face. Therefore, we offer a comprehensive Validation Toolkit to assist organizations in complying with required software validation documentation.