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.
The Vi-CELL BLU software employs a system of usernames and passwords to ensure that only authorized individuals can:
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:
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:
The MET ONE 3400+ air particle counter improves 21 CFR Part 11 compliance by
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.