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.
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.
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.
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:
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:
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.