21 CFR Part 11 Data Management Software

Software Capabilities

In a world where data integrity and regulatory compliance are critical, Osworld’s 21 CFR Part 11 compliant software stands out as the go-to solution for data logging. With global acceptance and a track record of exceeding industry standards, Osworld ensures not only compliance but also the optimization of your operations. Choose Osworld software to ensure that your operations are not just compliant, but also optimized for success. Experience the peace of mind that comes with knowing your data is secure, your processes are streamlined, and your business is ready to meet the challenges of today and tomorrow.

Osworld’s Web-Based Monitoring and Logging Software (OSLOG/WEB/16.1) is a validated, licensed application designed to seamlessly integrate with our equipment, enabling real-time logging of temperature and humidity. Hosted on a centralized server, it gathers data from multiple devices and allows users to monitor equipment from any operating system connected to the same Wi-Fi network. This powerful tool supports multiple departments within a facility, providing comprehensive monitoring and precise data logging through a single platform. In multi-department mode, admins can assign restricted, department-specific access rights, enhancing data security.

Why Choose Osworld Software?

21 CFR Part 11 Data Management Software

Achieve full regulatory compliance with these essential features

User Authentication

  • Unique User IDs
  • Password Protection
  • Role-Based Access Control (RBAC)

Audit Trail

  • Automated, Time-Stamped Logs
  • Event Tracking (Who, What, When)
  • Readable and Accessible Logsl

Electronic Signatures

  • Binding and Tamper-Proof
  • Dual Authentication (Username and Password)
  • Signature Manifestation (Name, Date, Purpose)

Data Integrity and Security

  • Data Encryption
  • Regular Data Backups
  • Access Logsl

Data Recording and Storage

  • Real-Time Data Acquisition
  • Data Redundancy
  • Long-Term Secure Storage

Report Generation

  • Automated and Customizable
    Reports
  • Multiple Export Formats (PDF, CSV)

Data Retention and Archiving

  • Defined Retention Period
  • Automatic Archiving

Notification and Alerts

  • Real-Time Alerts for Deviations
  • Customizable Alert Settings