21-CFR Part 11 Compliance
We have several families of data loggers and monitoring systems that offer software to allow them to operate under FDA 21-CFR Part 11 Compliance. They can be used in applications including pharmaceutical manufacturing and distribution, hospitals and life sciences, and food and beverage production.
There are 3 important groups of features for compliance with the CFR requirements:
- User management including secure user login. The system should also be able to maintain records of successful and unsuccessful login attempts. Furthermore, the system should allow for multiple levels of access with the ability to assign each user-specific permissions. The system should also provide for automatic log-out after a defined period of inactivity.
- Audit trail – the system should provide a comprehensive record of any changes to the configuration and settings of the system. This record should include the id of the user making the change, the date and time of the change, and the specific changes made to any user-customizable fields/settings. This would include such things as sample interval, alarm settings, alarm notification lists, calibration coefficients, and user account settings.
- Data storage in an unalterable format. Any recorded data and alarm events must be either encrypted or kept in an unalterable format to prevent after the fact modification to any historical data or event records.
In addition to this, there are several other 21-CFR Part 11 compliance features that provide additional functionality that most users find useful:
- Corrective action notes – In the case of alarms or other types of events, it is often useful to enter information as to both the cause of the problem and what was done to resolve the issue.
- Built-in report generation – In addition to the standard measured data reports, the ability to automatically create additional reports for login activity, configuration changes, and corrective action, and monthly data summaries for record-keeping.
Novus LogBox Data Loggers
Encrypted data records, strong authentication mechanism, password validity, event log, & audit trailLearn More
Lascar USB & WiFi Loggers
User logins with permissions, software & session audit trail, digital signatures, comment fieldsLearn More
Brainchild Paperless Recorders
Up to 30 users with password expiration, multiple access levels, login and audit trail, and auto logoutLearn More
With 9 access levels, up to 30 users, automatic inactivity logout, and automatic password expiration
User loging to download or access stored data, recorded data cannot be modified.
Audit Trail Function
To record when, who, and what changes are made to the logger configuration
In addition to standard events such as alarms provides a record of password failures and attempted unauthorized access
The Brainchild PR20 Paperless Chart Recorder with Optional CFR Firmware Provides is a Stand-Alone Electronic Chart Recorder with a Graphic Display, Support for up to 24 Analog Input Channels and On-Board Non-Volatile Data Storage. The Universal Analog Channels Support Thermocouples, RTD's, Voltage and Milliamp Inputs.
Pharmaceutical Clean Room Qualification Verifies Secure Operation
In the pharmaceutical industry, continuous and secure data acquisition and documentation is crucial for production and storage requirements, and also for research and development. Pharmaceutical clean room qualification verifies secure operation of environmental conditions in labs storing temperature-sensitive substances. According to FDA CFR21 Part 11, data acquisition and monitoring systems within cleanrooms must operate in compliance with GAMP/GMP guidelines.Read More