Learn how artificial intelligence (AI) and machine learning contribute to secure and compliant signing processes in the life sciences industry.
Regulatory compliance means that your products, systems, and services are created and maintained in a quality-first environment. It demonstrates to stakeholders and the public that your products are safe and effective. It also helps your organization avoid fines, penalties, and other repercussions due to non-compliance.
Discover How AI Contributes to Regulatory Compliance
Life sciences organizations that use electronic signatures (eSignatures) must adhere to U.S. Food and Drug Administration (FDA) 21 CFR Part 11 and European Union (EU) Annex 11 guidelines.
The intent of 21 CFR Part 11 is to maintain accountability and traceability of your electronic records, including eSignatures. It helps ensure that:
- System access is restricted to authorized individuals
- The system is able to detect and report attempts of unauthorized use
- Audit trails are built into the system
Annex 11 states that electronic signatures are expected to:
- Have the same impact as hand-written signatures
- Be permanently linked to their respective record
- Include the time and date they were obtained
To help support these requirements and expectations and make compliance seamless and effective, AI algorithms analyze behavior and patterns to detect suspicious activities. Machine learning algorithms are trained on vast amounts of historical data that enable a system to detect tampering or forgery.
Learn About AI’s Role in Audit Trails and Logging
An audit trail logs access to a system and what operations were performed by that user. When records are created, modified, or deleted, 21 CFR Part 11 requires that you know who did it and for what reason. It also requires that records are retained and are traceable by way of timestamps and version history.
To enhance security and help prevent unauthorized access to your eSignature system, AI-powered features like face or voice recognition can be used to authenticate users. Machine learning algorithms can also be used to detect suspicious activity.
Foster a Culture of Security Awareness
While AI does its part to protect against cyber threats and unauthorized access, it’s important to train your employees on compliance requirements to foster a culture of security awareness. Being familiar with information security (IS) policies and best practices and recognizing potential risks and threats helps keep your organization more secure.
When you collaborate with cybersecurity experts at USDM Life Sciences, you’ll have access to the knowledge and experience that helps your organization achieve FDA and other regulatory compliance expectations for good cybersecurity practices. The experts will also ensure that you meet standards like the General Data Protection Regulation (GDPR) in the EU and the Health Insurance Portability and Accountability Act (HIPAA) in the U.S.
Stay Ahead of Evolving Regulatory Standards
Regular audits and assessments ensure ongoing compliance with industry regulations. Continuous monitoring and periodic reassessment of validation methods are necessary to address technological advancements, comply with evolving regulatory standards, and maintain the integrity of electronic signatures throughout their lifecycle.
Another way that AI helps life sciences organizations stay ahead of evolving regulatory standards is through predictive analytics, which uses machine learning, historical data, and statistical algorithms. The result is the ability to anticipate the likelihood of regulation changes—and to predict certain customer behaviors, market trends, or equipment failures.
Read the white paper, Enhancing Security and Ensuring Data Integrity in eSignature Solutions, which identifies ways to simplify regulatory compliance for your organization.
How USDM Can Help
To simplify the validation burden for your IT teams, USDM’s Cloud Assurance as a Platform service maintains the continuous compliance of your GxP systems and environments. USDM executes automated regression testing and scripts on a monthly or weekly basis, or whenever releases are introduced. Where relevant, AI tools are used to support risk identification and mitigation activities.
We also ensure that AI-enhanced Software-as-a-Service (SaaS) solutions adapt to changes in technology and remain compliant with regulatory standards, including compliance with informed consent and data privacy regulations.
To reinforce your regulatory compliance, we assess vendor software and quality management system maturity. After we identify and remediate technical, process, personnel, or regulatory gaps, we help your organization leverage vendor activities to significantly reduce your compliance and maintenance burden.
USDM’s reputation is built on bringing clarity and action to the interplay of technology and regulations. We have more than 23 years of experience in the life sciences industry and stand ready to help you maintain continuous compliance. Contact us to get started today.