The Simple Western is now cGMP Ready
SANTA CLARA, Calif., July 1, 2013 /PRNewswire/ — ProteinSimple today released version 2.4 of Compass Software, which runs its Simple Western instruments complete with CFR Title 21 Part 11 compliance tools. With this software release, not only has ProteinSimple fully redesigned the age-old traditional Western and replaced it with a fully automated, fully quantitative platform, it has now enabled researchers to quickly and easily validate assays run on these systems to meet the standards defined by the FDA.
To comply with guidelines outlined in the Code of Federal Regulations title 21 part 11, validated systems must maintain electronic records, limit system access to authorized users, and be capable of generating time-stamped audit trails of user activity. ProteinSimple’s latest Compass Software enables researchers using the Simple Western in biopharmaceutical manufacturing and quality control groups to comply with these regulations and confidently manufacture and qualify their products.
The Simple Western is a Western with none of the hassle. No messy gels, no transfer tanks, no blots, and no manual analysis. Simply load up to 96 samples, push a button, walk away and come back to fully analyzed data. Now, with the latest Compass Software, researchers can easily validate their Simple Western work to ensure absolute data integrity.
“The rapid uptake of the Simple Western has taken it into labs from basic research and development all the way down-stream into biopharmaceutical analytical and manufacturing groups,” commented John Proctor, Director of Marketing at ProteinSimple. “System, software, and assay validation are important components of using the Simple Western in controlled environments. We are providing the necessary tools for scientists in these environments to be successful.”
Meet the entire Simple Western family at www.proteinsimple.com.
ProteinSimple’s goal is simply to help researchers gain a better understanding of proteins and their role in disease. The Company’s strategy is to power protein research by making it simpler and more quantitative, ultimately revealing new insights into the true nature of proteins. ProteinSimple has built a unique portfolio of protein analysis tools including systems for traditional protein imaging, systems to probe the structure and purity of protein based therapeutics and systems that provide fresh insight into protein signaling. ProteinSimple has over 170 employees, more than 14,000 systems installed around the world and is headquartered in Santa Clara, California. For more information, visit www.proteinsimple.com.