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

Echo 21 CFR 11 Compliance Manager (ECM) software adds 21 CFR Part 11 compliance support to Echo liquid handlers.

• System Administrator sets access to specific functions and roles enabled for each user profile, including protocol access and approval levels
• Organizes protocols and run report histories in a centralized location, with revision history on all protocols managed by ECM software
• Limits system access only to authorized individuals

Biomek i-Series liquid handlers include Beckman Coulter Accounts and Permissions (BCAP) software to enable 21 CFR Part 11 compliance. BCAP is an integrated set of features that assists users in complying with electronic signature requirements for its liquid handling operations, including:

• Single Administrator enables access level by creating, managing and setting roles and permissions for user accounts
• Limits system access only to authorized individuals
• Provides password protection for accessing, running and editing of protocols and liquid handling settings
• Facilitates audit trails to report all user activity in software applications

The 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

The software supports 21 CFR Part 11 regulations. Other features include a large touchscreen 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 MetaFLEX features the following key system components to facilitate 21 CFR 11 compliance:

• Sample results log: 2000
• Activity log: 5000
• Calibration adjustment log: 1000
• Data secured by password protection
• Electronic signature capability
• Secure user sign-on
• 8 user-level permissions
• Administrative configuration tools

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 (RFID not available in all geographies) are:

• Certified value
• Lot number
• Expiration date

The HHPC+ Series counters allow easy ISO Class 5 to 7 monitoring in hard-to-reach places.

• 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 enables 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 21 CFR 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