New 21 CFR Part 11 Software Broadens Applications of Varian’s 1200L LC/MS Within the Pharmaceutical Industry
Varian, Inc. today announced that it has completed the extension of 21 CFR Part 11 tools across its full line of Chromatography and Mass Spectrometry software platforms. The introduction of Varian’s new MS Workstation 6.3 with 21 CFR Part 11 tools allows customers using Varian’s 1200L LC/MS system for pharmaceutical applications to comply with the FDA’s regulations requiring Access Control, Audit Trails, and Validation.
The 21 CFR Part 11 regulation was adopted by the FDA in 1999 to help ensure quality control through accurate and secure record keeping across the biopharmaceutical industry and its supply network. The new compliant MS Workstation 6.3 software allows customers within this industry to document their activities using required electronic signatures and record keeping. Varian’s 1200L LC/MS system is becoming increasingly valued by researchers needing to make sensitive determinations on both large and small molecules (using the optional GC/MS interface), and the line extension will ensure accurate documentation of their activities.
Key features of the new MS Workstation 6.3 software include: Access Control that allows for use only by appropriately trained persons, Audit Trails that documents the original file and tracks all modifications, and Validation to ensure proper system functioning.
“Since the 2002 launch of the 1200L LC/MS, there has been an extremely positive response to the system by pharmaceutical customers,” said Martin O’Donoghue, vice president of scientific instruments, Varian, Inc. “The new 21 CFR Part 11 tools allow these researchers to continue to benefit from the functionality and versatility of the system as they comply with FDA quality standards.”
Uniquely, the 1200L LC/MS system can be configured to meet a customer’s specific analytical requirements. The system is available as a triple- quadrupole or as a single-quadrupole MS that can later be upgraded to triple- quadrupole. In addition, both configurations allow the user to switch from LC/MS to GC/MS and back, with a simple interface change. The MS Workstation 6.3 software with 21 CFR Part 11 tools can be used with any configuration of the system.
