LORENZ Passes GAMP 4 Audit
GUILDFORD, UNITED KINGDOM: LORENZ today announced that it’s development arm, LORENZ Bridge Software, has passed an audit following the GAMP 4 model. LORENZ Bridge Software is part of the Life Science Group and is the developer of docuBridge, the world’s leading submission management software.
The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacturing is the most widely used and internationally accepted guideline for the validation of computer systems. The guideline is produced by ISPE and the GAMP Forum (http://www.ispe.org/gamp).
"This is an important milestone for our development environment," says Akira Yamaguchi, VP Product Marketing & Development. "Customers can rest assured that software being developed at LORENZ fully complies with the most up-to-date guidelines - a statement few companies can make. It also underlines the importance we place on a transparent development environment, much to the benefit of our customers."
"GAMP 4 will allow us to maintain compliance and demonstrate this with the appropriate documentation," says Jan Wermusch, VP R&D / QA. "Also, it will result in even lower operational and maintenance costs for our customers."
The audit report enables LORENZ' customers to apply internal QA standards without or with reduced supplier audits, saving time and resources.
The audit was performed by GITP - Good Information Technology Practices and directed by Dr. Heinrich Hambloch.