Maintaining FDA Compliance with Arxspan: Best Practices for Streamlining Data Management and Regulatory Requirements
The pharmaceutical and life sciences industries face strict regulations from the FDA when it comes to managing scientific data. Arxspan offers a comprehensive solution that includes all the features mandated by by 21 CFR Part 11, ensuring that researchers can maintain compliance while benefiting from the flexibility and ease of use of the digital platform.
Understanding 21 CFR Part 11 Regulations:
21 CFR Part 11 is a regulation issued by the United States Food and Drug Administration (FDA) that outlines the guidelines for electronic records and electronic signatures used in FDA-regulated industries. This regulation was introduced to ensure the security, integrity, and confidentiality of electronic records and signatures, as well as to prevent fraudulent practices. Compliance with 21 CFR Part 11 is mandatory for organizations that operate within the FDA-regulated industry. For more information about 21 CFR Part 11 and its compliance requirements, please refer to the official FDA website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application.
Armed with the latest in data management technology, 21 CFR Part 11 regulations gives organizations full authority to apply electronic signatures to completed works.
Streamlining Scientific Workflows with Electronic Signatures and Witnessing in Arxspan:
Arxspan offers an electronic signature and witnessing feature that simplifies scientific workflows, ensuring compliance with regulatory guidelines. Users can easily sign experiments and ensure compliance with regulatory guidelines. Arxspan’s electronic signature and witnessing feature make it simple, efficient, and completed with just a few clicks, allowing users to focus on their research and maintain productivity.
Audit Trail:
Arxspan’s system maintains an audit trail, a recorded history of all changes made within the system, accessible through the “History” option in the left menu bar. The audit trail allows users to view all relevant details regarding changes made in the system over time.
User Management – Organization Admin:
Arxspan’s User Management section allows the configuration of user access and permissions controlled by administrators of the system. Access to individual work items can be specified at the user and/or group level, including view-only or add/write permissions. Administrators can grant further sharing permissions as needed.
Security:
Arxspan includes various security features such as password expiration settings, session timeout settings, compatibility with SSO (i.e., SAML Okta), and user login history accessible only by administrators.
Conclusion:
Arxspan offers a comprehensive scientific data management solution with the features necessary for 21 CFR Part 11 compliant features, ensuring compliance with FDA regulations. Arxspan’s electronic signature and witnessing feature, audit trail, user management, and security features streamline scientific workflows, simplifying data management and maintaining compliance with regulatory guidelines.
