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Yet with this progress comes a renewed focus on regulatory compliance, particularly around how organizations manage, store, and secure electronic data. FDA 21 CFR Part 11 is the U.S. regulation that defines the standards for electronic records and electronic signatures used in regulated environments such as pharmaceuticals, biotechnology, and medical devices.
It’s a framework for ensuring data integrity, authenticity, and reliability across every stage of the product lifecycle. As organizations move away from paper-based systems, the challenge lies in maintaining these principles within modern digital infrastructures. Fortunately, B2B SaaS compliance solutions are rising to meet this demand.
Secure cloud life sciences systems, automated audit trails, and artificial intelligence (AI) are reshaping how compliance is achieved and sustained.
Together, these innovations are supporting FDA 21 CFR Part 11 compliance and the industry’s broader mission of advancing science with integrity and accountability.
Secure cloud systems for FDA 21 CFR Part 11 compliance
Managing critical data and workflows is an integral everyday activity for life sciences organizations, and they are increasingly turning to cloud-based platforms to achieve this. However, the shift towards online-only systems brings the obligation to comply with FDA 21 CFR Part 11, the regulation that governs the integrity, authenticity, and confidentiality of electronic data used in regulated environments.
Modern and secure cloud systems were custom-built to align with these regulatory expectations, protecting the records from unauthorized access, tampering, or loss. A key part of compliance is meeting the trustworthy and reliable standards for electronic records, achieved through:
| Security feature | Compliance relevance |
| Granular Access Controls | Role-based permissions and identity verification protocols (such as multi-factor authentication) ensure that only authorized personnel can access or modify sensitive data. |
| Encrypted Storage and Transmission | Data is encrypted both at rest and in transit, safeguarding records against interception or corruption. |
| Audit Trails Compliance | Automated logs document every user action, from creation to modification, and deletion, providing a transparent history for traceability and accountability. |
| Validated System Environments | Leading cloud providers test their systems to demonstrate they operate consistently, accurately, and in accordance with expectations for system validation. |
| Data Backup and Redundancy | Continuous backups and geographically distributed storage ensure that records remain readily retrievable throughout their retention period, satisfying FDA requirements for long-term accessibility. |
These security features enable cloud-based systems to not only comply with FDA 21 CFR Part 11, but they also enhance operational efficiency, scaling the digital ecosystem.
Audit trails for regulatory traceability
Under FDA 21 CFR Part 11, maintaining a clear and verifiable history of data activity is a fundamental requirement.
Audit trails serve as its backbone, providing an unalterable record of who performed what action, when, and why. These records ensure accuracy and provide a clear route for accountability, in case things go wrong.
Fortunately, record creation, modification, approval, and storage can all be automated. Each step is time-stamped, attributed to a verified user, and stored in a secure, tamper-evident log. This eliminates the manual recordkeeping risks while ensuring that every change is verifiable and traceable.
Key features include:
- Immutable recordkeeping: once an event is logged, it cannot be altered or deleted, preserving the authenticity and reliability of the record
- User ID and authentication: every action is tied to a unique, authenticated user identity, preventing anonymous or unauthorized changes
- Time-stamping: precise time logging enables auditors to reconstruct sequences of events with confidence
- Metadata: data entries include contextual details such as reason for change or associated approval, providing full transparency around decision-making and data manipulation
- Automated reporting: built-in tools enable rapid retrieval of historical data, simplifying audit prep
AI’s role in supporting compliance monitoring
In life sciences, AI is becoming a critical ally - enhancing the ability to monitor, validate, and secure data in real time. It can help organisations to manage growing volumes of electronic data while maintaining continuous compliance with FDA 21 CFR Part 11.
Real-time data validation
Machine learning models can automatically verify the completeness, consistency, and accuracy of data as it’s entered or modified. This proactive validation minimizes human error, ensuring that all electronic records meet regulatory standards for data integrity.
Anomaly detection
AI continuously analyzes data patterns to identify irregular activities such as
- unauthorized access attempts
- unexpected data modifications
- deviations from established workflows
When anomalies are detected, the system triggers instant alerts, enabling rapid corrective action before compliance risks escalate.
Automated reporting
AI compliance monitoring can compile audit-ready reports, summarizing compliance status, user activity, and potential issues. This not only streamlines internal reviews but also supports smoother regulatory inspections by providing transparent and verifiable data history.
An added benefit: by learning from historical audit trails and system interactions, AI can anticipate areas of potential noncompliance. This allows organizations to address vulnerabilities before they result in enforcement action.
Through automation and predictive analytics, AI-driven systems help ensure that electronic records remain accurate, consistent, and compliant throughout their lifecycle.
FDA 21 CFR Part 11 compliance
Achieving FDA 21 CFR Part 11 compliance has evolved from a regulatory checkbox into a strategic enabler of trust and efficiency. In 2025, organizations can leverage AI and cloud platforms to automate audit trails and set a new standard for data integrity.
By embracing digital solutions built around security, traceability, and intelligence, companies can safeguard their data’s integrity, streamline inspections, and sustain regulatory success in an increasingly data-driven future. Global Relay’s AI-powered cloud archive enables users to gain deep insights while maintaining the ability to forensically drill down into the data.
Securely manage your electronic records, streamline the compliance process, and find, analyze, and share data in seconds. Book a demo to learn more.
