OpenText™ ALM/Quality Center serves as the single pane of glass for software quality management. It helps you govern application lifecycle management activities and implement rigorous, auditable lifecycle processes.
Yes. Computer System Validation (CSV) is the process of testing/validating a regulated computerized system to ensure that it does exactly what it is designed to do and providing detailed documentation of evidence to demonstrate compliance. CSV is required by FDA's 21 CFR Part 11, EU Annex 11, GAMP5 guidelines, ICH Q7 guidelines and others. ALM/Quality Center is a tool with advanced quality assurance capabilities that well meet the needs of CSV. You can use e-signature to sign the validation records managed in ALM/Quality Center. Learn more about ALM-based Computer System Validation.