Pharma and Life Sciences companies (e.g. pharmaceutical, biotech, medical device) operate in a demanding and highly regulated environment. These organizations must maintain a high level of compliance with numerous regulatory requirements such as Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), FDA 21 CFR Part 11, Sarbanes-Oxley (SOX), and ISO standards. TMS software is a simplified, centralized system that offers an integrated approach for managing compliance and quality processes such as CAPAs, complaints, audits, document control and training management.
With TMS solutions companies can: