Validating Computer Systems for 21 CFR Part 11 Compliance

Validating Computer Systems for 21 CFR Part 11 Compliance 

21 CFR Part 11, Electronic Records; Electronic Signatures applies to companies that have decided to maintain electronic records and submit these documents to the Food and Drug Administration (FDA). Part 11 is applicable to electronic records that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. Computer systems used for these electronic records and electronic signatures must be validated to ensure accurate, reliable, and consistent performance. Also, to be able to recognize invalid or altered records. Since pharmaceutical companies are leaning towards electronic records, most will find the 21 CFR Part 11 applicable. 

The regulation is divided into three main subparts: 

• Subpart A: General Provisions, outlining the scope and definitions. 

• Subpart B: Electronic Records, detailing the control requirements for records managed by computerized systems. 

• Subpart C: Electronic Signatures, specifying how electronic signatures should function and be managed.  

The FDA considers software validation to be “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.” 

Software validation is a means of avoiding defects and recalls due to software failures or due to changes to the software after initial production and distribution, which contributes to a big percentage of defects. All production and/or quality system software, even if purchased off-the-shelf, should have documented requirements that fully define its intended use, to ensure that it will perform as intended, and information against which testing results and other evidence can be compared, to show that the software is validated for its intended use. 

System Validation Documentation 

For compliance with 21 CFR Part 11, essential documentation requirements include system validation, user access controls, audit trails, test plans, and standard operating procedures (SOPs) that ensure the integrity and security of electronic records. Listed below are some of the documentations and testing protocols produced during a validation process. 

Validation Plan 

Defines the scope of validation activities and sets out the validation objectives. This details the methodologies, protocols, and acceptance criteria for validating the system to confirm that it meets all operational and regulatory standards. 

Requirements and Specifications 

Requirements represent the expressed or implied needs of the customer. These are usually stated in functional terms and are refreshed as the project progresses. A specification is defined as “a document that states requirements.” These specify the methods and criteria for verifying compliance with the requirements. 

IQ/OQ/PQ 

Industry documents and FDA guidance often explain user site software validation through installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). 

IQ 

Installation Qualification is the process of verifying that the software or system is installed correctly and configured according to design specifications. The main objectives of IQ include documenting and approving all documented installation protocols and processes; confirming that the system has been installed as per the manufacturer's specifications; ensuring that any necessary utilities (like power, network, etc.) are configured and functioning correctly. 

OQ 

Operational Qualification involves testing the installed system to ensure that it functions according to predefined conditions and specifications. This often includes: Verifying that all major functionalities of the system are working as intended, Conducting tests under various operational conditions to ensure reliability and performance within specified operational ranges, Documenting any discrepancies or issues that arise during testing, providing further insights into the system's reliability under normal usage conditions. 

PQ 

Performance Qualification is the final phase of validation, focusing on the system's performance in real-world conditions. This includes validating that the system performs effectively under simulated or actual user loads; testing the system's ability to consistently produce quality outputs over time; ensuring that the overall system meets user requirements and expectations in operational conditions. 

Requirements Traceability Matrix (RTM) 

The RTM serves as a vital tool in project management, particularly in software development, by establishing a comprehensive link between project requirements and their corresponding deliverables. It ensures that all requirements are not only documented but also tracked throughout the project lifecycle, thereby enhancing visibility and accountability. 

Validation Summary Report 

At the end of the validation process, a summary report should be generated. This report encapsulates all validation activities, results, and conclusions, and certifies that the system has been validated for its intended use. 

Lifecycle Management 

Both the General Principles of Software Validation and CFR Part 11 stress the importance of lifecycle management for maintaining compliance and validation effectiveness. Proper management of the software development lifecycle, from inception to deployment, ensures that all regulatory requirements are met throughout the process, aligning with the FDA’s expectations for software used in regulated applications. It is recommended that software validation shall be conducted throughout the entire software life cycle.  

Key Components of Life Cycle Management: 

Validation: 

Systems must undergo validation to confirm their capabilities for creating and managing electronic records as intended. Validation includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)  

Each stage involves specific protocols to ensure systems operate correctly and meet regulatory requirements.  

Documentation: 

Compliance demands comprehensive documentation that tracks process performance and changes. This includes but is not limited to audit trails, validation protocols, and configurations.  

Risk Assessment: 

A risk-based approach to validation is essential to prioritize validation efforts based on the potential impact of the system on product quality and data integrity. Systems are assessed for risks that could affect compliance outcomes.  

Continuous Monitoring: 

Ongoing monitoring of systems ensures they remain in a validated state. This involves system checks and balances such as user access limits, regular audits, and reviews to detect any unauthorized changes or data integrity issues.  

Training: 

Employees must be trained adequately on system use and compliance requirements. Continuous training helps maintain an organization’s compliance posture.  

Partner with Arbour Group for 21 CFR Part 11 Compliance Success 

Software validation ensures device software and automated operations are more reliable and easier to use, which means fewer failures, recalls, and risks for patients and users, and less liability for manufacturers. Arbour Group provides software validation through a process of planning, statement of requirements, test development, execution, and summary reporting. These documentations are thoroughly reviewed to ensure compliance. 

Ensure your computer systems meet 21 CFR Part 11 requirements with confidence. Contact Arbour Group today to learn how our expert validation services can help you achieve full compliance, reduce regulatory risk, and maintain data integrity across your digital operations.