21 CFR Part 11 Related Products: Beckman Instruments for Data Integrity and Compliance

New software supports 21 CFR Part 11 regulations. Other features include a large touch-screen display, remote monitoring and control, and increased security and tracking features.

• Requires username and PIN authentication to operate
• User specific pre-defined programs limit potential for errors
• Records data usage by user, providing an audit trail of centrifuge activities
• Provides read-only records

The Vi-CELL BLU software employs a system of usernames and passwords to ensure that only authorized individuals can:

• Use the system
• Electronically sign a record
• Access the operation or computer system input or output device
• Alter a record
• Perform the operation at hand

New software supports 21 CFR Part 11 regulations. Other features include a large touch-screen display, remote monitoring and control, and increased security and tracking features.

• Requires username and PIN authentication to operate
• User specific pre-defined programs limit potential for errors
• Records data usage by user, providing an audit trail of centrifuge activities
• Provides read-only records

Customer Responsibility: Compliance with 21 CFR Part 111 can only be met in connection with the operational environment.  The requirements for such an environment include:

• Technical environment and data management
• Training
• Administration
• Standard Operating Procedures (SOP)

Use for on-line release testing for conductivity and TOC analysis. The PAT700 contains all necessary SOPs in electronic format and calibration standards that are automatically imported into the instrument via RFID are:

• Certified value
• Lot number
• Expiration date

• Lightweight and comfortable for hard to reach HEPA filter leaks
• Quickly check or validate ISO Class 5 (FED STD Class 100) or higher cleanrooms and controlled environments
• Slim design allows single handed operation for effortless troubleshooting of filter leaks

The MET ONE 3400+ air particle counter improves 21 CFR Part 11 compliance by

• Enabling cleanroom sampling SOPs to be loaded and recalled by simply selecting the location name from the on-screen menu
• Sending electronic records straight from the counter to a secure server for IT to implement 21 CFR Part 11 secure controls

Use the HIAC 9703+ for final product sub-visible particulate counting in parenteral drug products. Electronic SOP functionality in HIAC PharmSpec software allows the electronic test results database to be kept remotely on a secure server, where the IT department can implement 21CFR part 11 secure controls.

Software tools can facilitate compliance with 21 CFR Part 11. Technical controls provide functions that ensure the reliability and integrity of electronic records and signatures. The CytExpert Electronic Record Management installation option for the CytoFLEX flow cytometer platform, has been designed to offer:

• Controlled access to the closed system using passwords and permissions
• Data integrity control using checksum and audit trails
• Document control using signatures, signature hierarchy and file retention