Software Validation and Standards

Software Validation

Software validation refers to the process of confirming that a software system meets the requirements it was designed for and performs accurately and consistently. Validation is essential in industries where software plays a crucial role in maintaining quality and safety standards, particularly in the life science sector. Various regulations, standards, and guidelines mandate that Quality Management Systems (QMS) software, including Electronic Quality Management Systems (eQMS), be validated before they are implemented and maintained.

Key Standards and Regulations

There are multiple standards and regulations governing software validation in various industries. Some of the most prominent ones include:

• ISO 13485:2016: An international standard that specifies the requirements for a quality management system for medical devices. It requires computer software used in the quality management system to be validated before use. The validation activities need to be equivalent to the risk associated with the use of the software.

• FDA 21 CFR Part 820: Known as the quality system regulation, this establishes current Good Manufacturing Practice (cGMP) requirements for medical devices. Section 21 CFR 820.70(i) states that manufacturers must validate computer or automated data processing systems when used as part of the quality system.

• FDA 21 CFR Part 11: This regulation sets forth the criteria for electronic records, signatures, and computer systems to be trustworthy and reliable. Section 21 CFR 11.10(a) specifies that systems must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

• EU GMP Annex 11: Provides the Good Manufacturing Practices (GMP) on the use of computerized systems in the Life Sciences. Section 4 provides general principles for validating computerized systems used in manufacturing pharmaceutical products.

Steps in the Validation Process

To ensure that software systems are fit for their intended use, the validation process follows a structured approach. Generally, it comprises the following steps:

1. Risk Management: Identifying potential risks associated with software development, updates, and implementation. Risks can relate to the software's functionality, performance, security, and usability. Performing a comprehensive risk assessment helps in developing a risk-based test plan and executing effective test cases.

2. Validation Planning: Creating a validation plan outlining the system's scope, development methodology, validation measures, and associated procedures. The plan serves as a roadmap for conducting validation activities and provides a framework for measuring the success of these efforts.

3. Installation Qualification (IQ): Verifying that the installed software meets the design and installation requirements. IQ typically involves comparing the as-installed configuration against the as-designed configuration.

4. Operational Qualification (OQ): Confirming that the software functions as intended during normal operation. This may involve testing the software with typical usage scenarios and verifying its compatibility with hardware and other software components.

5. Performance Qualification (PQ): Assessing the software's performance under realistic conditions to ensure consistency and reliability. PQ may include stress testing and load balancing to evaluate the software's ability to handle peak loads without compromising performance.

6. Validation Reporting: Documenting the validation results in a clear and concise manner. This includes creating a validation certificate summarizing the validation process, risks, test results, and conclusions.