Title 21 CFR Part 11 consulting
Meet software compliance requirements in a regulated environment
Regulatory compliance
Ensuring software meets 21 CFR Part 11 requirements
Technical solutions
Best solutions for identified areas of non-compliance
Seamless integration
Compliance features integrated into existing or new software
21 CFR Part 11 compliance for IVD medical devices and GxP applications
Work with our experienced consultants to build a 21 CFR Part 11-ready software for your target market. Our experts have hands-on experience in IVD medical device industry, clinical trials, and GxP-ready software development.
We assist you in conducting a thorough gap analysis of your existing computer systems and software applications to identify areas of non-compliance.
We then recommend best practices and technical solutions to ensure full compliance with the regulation. If you do not have existing software, we can develop a compliant solution from the ground up to meet all regulatory and quality management requirements.
Thorough 21 CFR Part 11 consulting services
Our 21 CFR Part 11 consulting services include:
Compliance Analysis
Our consultants thoroughly analyze your existing software applications to identify areas of non-compliance with 21 CFR Part 11. This includes reviewing current practices, documentation, and technical setups.
Recommendations and Solutions
Based on the compliance analysis, we provide tailored recommendations and technical solutions to address identified gaps. Our experts advise on best practices and necessary changes to ensure full compliance with the regulation.
Feature Development and Implementation
Working closely with your development team, we assist in developing and implementing 21 CFR Part 11 features, such as electronic signatures, into your software. This ensures that all regulatory requirements are met efficiently and effectively.
Documentation Support
We provide comprehensive support for creating and maintaining software-related documentation required for the companies operating in this FDA-regulated environment.
Discover how to implement 21 CFR Part 11 features into your software
The main 21 CFR Part 11 software features include authentication, audit trails, data export, and electronic signatures to ensure data integrity.
To help you better understand how to implement all of these features into your software, we’ve prepared a dedicated blog article on the topic. Read more to explore key steps, best practices, and answers to common questions that will guide you toward achieving compliance with the FDA regulations.
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Frequently asked questions (FAQs)
What is 21 CFR Part 11?
21 CFR Part 11 is an FDA regulation that defines when electronic records and electronic signatures can be considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.
It applies to FDA-regulated companies that use electronic systems to create, modify, maintain, archive, retrieve, or transmit records required by FDA regulations. To comply, organizations must implement appropriate technical and procedural controls, such as audit trails, user access controls, electronic signatures, and system validation.
Who needs to comply with 21 CFR Part 11?
Organizations that use electronic records or electronic signatures as part of FDA-regulated activities should assess whether 21 CFR Part 11 applies to their systems and processes.
This commonly includes pharmaceutical and biotechnology companies, medical device manufacturers, clinical research organizations, and other organizations maintaining records required under FDA regulations.
Can you assess whether our software complies with 21 CFR Part 11?
Yes. We can review your software and assess how well it aligns with 21 CFR Part 11 requirements. Our assessment typically covers areas such as audit trails, electronic signatures, user access management, data integrity, system validation, and supporting documentation.
We identify compliance gaps, explain their potential impact, and provide practical recommendations to help you achieve or improve compliance.
What features should software include to support 21 CFR Part 11 compliance?
Depending on its intended use, software supporting 21 CFR Part 11 compliance may require controls such as unique user identification, controlled system access, computer-generated audit trails, electronic signatures, record protection and retention, and controls that preserve data integrity.
Technical features alone are not enough. Compliance also depends on system validation, procedures, training, security controls, and how the organization actually uses and maintains the system.
Can existing software be upgraded to support 21 CFR Part 11?
Often, yes. Existing software can frequently be enhanced with features such as audit trails, electronic signatures, access controls, and improved record management.
However, adding features alone does not establish compliance. We assess the software architecture, intended use, existing controls, documentation, and validation needs and recommend whether targeted improvements or broader modernization is the most practical approach.
Does using Part 11-compliant software automatically make my company compliant?
No. There is no FDA certification for “21 CFR Part 11-compliant software,” and software alone cannot make an organization compliant.
While software should provide features such as audit trails, electronic signatures, and user access controls, compliance also depends on how the system is configured, validated, maintained, and used within your quality system. Policies, procedures, training, and operational controls are all essential parts of achieving compliance.
What is the role of Computer System Validation (CSV) in 21 CFR Part 11 compliance?
Computer System Validation (CSV) provides documented evidence that a computerized system performs as intended and is suitable for its intended use. For systems subject to 21 CFR Part 11, validation is an important part of demonstrating that the system’s controls operate reliably and consistently.
A risk-based validation approach typically considers requirements, intended use, risks, testing, traceability, and documented evidence throughout the system lifecycle.
Comprehensive software development services
We support your software development project at every stage, from software documentation to UX design and cybersecurity, along with many other services, helping you bring your product to market faster.
