Understanding FDA Software Validation
Blog | December 20th, 2022

Understanding FDA Software Validation

According to FDA 21 CFR Part 820.70(i), any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use. In our video CQ’s Software Validation Approach for Life Sciences Companies, we discuss in detail the need for an FDA-regulated company to establish recorded evidence that demonstrates and verifies that the software used meets the compliance and quality management criteria.

The FDA software validation also helps organizations to implement Good Manufacturing Practice (GMP) guidelines. The FDA has compiled comprehensive guidance that is applicable to the validation of medical device software or the software used to design, develop or manufacture medical devices.

According to FDA, software validation is the “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.”

Purpose of FDA Software Validation

All companies subject to FDA regulations must validate any software, including the software used as components in medical devices, software that is itself a medical device, and software used in the production of the device or in the implementation of the device manufacturer’s quality system. This is applicable to –

  • Any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or any other aspect of the quality system.
  • Any computer system used to create, modify or maintain electronic records and signatures.

As such, there are only two rules for FDA software validation:

  • All the products manufactured and the processes used must meet the FDA’s production and inventory management criteria
  • Every step of the validation process must be documented

As the world of standards moves towards a risk-based approach, FDA reinforces this approach with Computer Software Assurance (CSA). The new CSA understands these challenges and is focused on easing many of the requirements by narrowing them down to risks and critical quality attributes (CQA).

Methods of Software Validation

FDA follows the ‘4Q lifecycle model’, which includes four qualification aspects – design, installation, operational and performance.

  • Design Qualification (DQ) focuses on various specifications including user requirement, functional, operational and vendor.
  • Installation Qualification (IQ), where FDA validates if the software arrived as purchased and the installation of hardware and software is in accordance with the vendor and user specifications.
  • Operational Qualification (OQ) is conducted to test the key operational and security functions to establish the success of the installation and whether the software is performing as intended.
  • Performance Qualification (PQ) tests the specified application while focusing on preventive maintenance and performance tests to ensure the software meets all the FDA requirements for functionality and safety.

Here is a checklist for ‘Basic Steps of Computer System Validation & Regulatory Requirements.’

Steps Involved in Software Validation

Software validation is a critical tool used to

  • assure the quality of device software and software automated operations
  • increase the usability and reliability of the device
  • reduce long-term costs and the cost of validation

Broadly, there are five steps to FDA software validation.

Step 1: Create a validation plan that documents various aspects of the software system, its installed environment and project limitations. The plan will also include the testing and acceptance criteria, development procedures and responsibilities of the members of the validation team.

Step 2: Determine system requirements (SRS) by outlining the conditions, including infrastructural, equipment and functional requirements. Perform a risk analysis to identify gaps in the functional requirements.

Step 3: Create a validation protocol and test specifications to uncover potential errors and to check whether all the key features are performing properly.

Step 4: Conduct tests and document results into various categories, including successes, errors and failures.

Step 5: Establish procedures and write the final report that includes a detailed description of support, training, secure backup and recovery, before releasing the system for use within the company.

With CQ EQMS, it becomes easy to automate the process of FDA Software Validation, including all training and document management. Additionally, with CQ – it becomes simple to collaborate with relevant stakeholders as needed and manage change in case any issues come up during the validation process.

Request a demo here: https://www.compliancequest.com/lp/eqms/

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