FDA Software validation is a requirement of the FDA Quality System Regulation, which was published in the Federal Register on October 7, 1996, and took effect on June 1, 1997 (See Title 21 Code of Federal Regulations (CFR) Part 820, and 61 Federal Register (FR) 52602, respectively). Validation requirements apply to software used as components in medical devices for ISO 13485 and ISO 9001 compliance and in our tools such as audit management software used in the production of the device or in the implementation of the device manufacturer’s quality system.
What is the Purpose of FDA Software Validation?
Any software used to automate the device production process or the quality system must be validated for its intended use, as required by 21 CFR 820.70(i). This requirement applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system.
In addition, computer systems used to create, modify, and maintain electronic records and to manage electronic signatures are also subject to the validation requirements. (See 21 CFR 11.10(a)) Such computer systems must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to separate invalid or altered records. In accordance with the FDA software validation guidelines, we assist customers in validating CQ solutions. We support you throughout the process of validating the entire solution.
Once the solution is installed, CQ will assist you with the following:
- Installation Qualification (IQ): Ensures that the solution is installed properly.
- Operational Qualification (OQ): Establishes documented evidence that operating characteristics perform within the limits and specifications defined for the system.
- Performance Qualification (PQ): Allows conversion of the OQ to PQ to establish documented evidence of consistent performance as defined for the system.
- Functional Requirement Specifications (FRS): Provides design and test traceability.