Powering Compliance and Innovation in Life Sciences
What is 21 CFR Part 11?
In the life sciences industry, 21 CFR Part 11 establishes the standards for maintaining and controlling electronic records and electronic signatures (eSignatures). For companies choosing to use electronic systems to create, modify, or maintain records required by predicate rules, Part 11 ensures these records are trustworthy, traceable, and compliant.
At its core, Part 11 is about accountability, traceability, and security. It requires companies to answer key questions, such as:
- Is system access restricted to authorized individuals?
- Are authority checks in place to ensure that only authorized personnel can electronically sign, alter, or access records?
- Does the system log all electronic signatures with details like the signer’s name, timestamp, and the purpose of the signature?
- Are audit trails robust enough to record and prevent unauthorized alterations?
- Can the system detect and report unauthorized access attempts in real-time?
USDM Life Sciences ensures that your organization meets these rigorous standards. With comprehensive expertise in regulatory compliance, USDM supports the life sciences industry in building robust processes, implementing secure systems, and fostering a compliance-driven culture.
Building Trust and Compliance Through Audit-Ready Processes
Trust & Compliance is foundational to maintaining the integrity and resilience of life sciences organizations. At USDM, we integrate this pillar into all aspects of 21 CFR Part 11 compliance.
Key Compliance Measures for 21 CFR Part 11:
- Audit Trails: Systems must track user actions, including who accessed, modified, or deleted records, along with timestamps and version histories. Event logs alone are insufficient; compliance requires granular traceability.
- Access Control: Implementing robust user authentication processes to prevent unauthorized system access.
- Continuous Monitoring: Proactively identifying risks and mitigating them to secure data integrity.
USDM’s Cloud Assurance™ service ensures that your electronic systems are fully compliant with GxP standards and ready for audits. From risk assessments to proactive monitoring, we support organizations in maintaining compliance across their entire operation.
Automating Compliance with Workflow Automation
Manual processes often lead to inefficiencies and errors. With Intelligent Workflow Automation, USDM transforms compliance into a seamless, integrated component of everyday operations. Automated workflows ensure compliance by embedding regulatory checks into processes, eliminating human error, and streamlining repetitive tasks.
Benefits of Workflow Automation for Part 11:
- Automated validation processes reduce the time and effort spent on compliance.
- GenAI-powered agents intelligently handle routine tasks, enabling teams to focus on higher-value activities.
- Integration with quality management systems (QMS) ensures traceable, audit-ready workflows.
For example, leveraging GenAI agents and tools like ProcessX on ServiceNow, USDM enhances quality processes with precision automation, ensuring every step adheres to 21 CFR Part 11 requirements.
Leveraging Data Insight and Control for Smarter Decisions
Data is the backbone of compliance and operational excellence. With USDM’s Data Insight and Control, life sciences companies can transform raw data into actionable insights while maintaining strict adherence to regulatory standards.
Core Elements of Data Control for Compliance:
- Data Integrity: Ensuring the accuracy, consistency, and reliability of records.
- Governance Frameworks: Implementing policies for secure data handling, privacy, and traceability.
- Integration: Seamlessly connecting disparate systems for cohesive operations.
By unifying data across platforms, USDM enables real-time monitoring and predictive analytics, driving smarter decisions and streamlined compliance efforts.
Discover the various applications of AI for eSignatures in this white paper.
Ensuring Content Compliance with Document Management
Effective document management is critical for maintaining compliance with 21 CFR Part 11. USDM’s Content Management capability provides structured, scalable solutions to manage unstructured content, ensuring accessibility and regulatory adherence.
Highlights of Document Management:
- eSignature Compliance: Systems like DocuSign and Adobe Sign are integrated with regulatory safeguards, ensuring legally binding and traceable electronic signatures.
- Version Control: Maintaining complete histories of document revisions and enabling retrieval of previous versions for audit purposes.
- Metadata Management: Enhancing document searchability and usability for faster access to critical information.
With USDM’s solutions, life sciences companies can confidently manage the entire lifecycle of regulatory content, from creation to archival, while preparing for the future of AI-powered insights.
Driving Compliance in the Cloud
As life sciences organizations increasingly migrate to the cloud, maintaining compliance remains a top priority. USDM specializes in cloud solutions that ensure your operations meet 21 CFR Part 11 requirements while leveraging the flexibility and cost-effectiveness of cloud technologies.
How USDM Supports Cloud Compliance:
- Cloud Assurance: A comprehensive service ensuring end-to-end compliance for your cloud-based systems, from implementation to ongoing validation.
- Vendor Selection: USDM partners with leading software providers to deliver compliant solutions tailored to your business needs.
Whether it’s enabling secure eSignatures with DocuSign or optimizing data storage in a hybrid environment, USDM provides the expertise and tools to integrate compliance seamlessly into cloud strategies.
Partner with USDM for Seamless 21 CFR Part 11 Compliance
USDM brings together the best of technology, regulatory expertise, and innovative solutions to simplify 21 CFR Part 11 compliance. Our unique combination of Trust & Compliance, Workflow Automation, Data Insight and Control, and Content Management ensures that your organization remains compliant, efficient, and future-ready. Contact us to discuss how we can help you achieve compliance and transform your operations.
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