Orchestrate your pharmaceutical validation processes with codebeamer X’s Pharma GAMP® 5 Template. Adhere to GAMP® guidelines, and maintain focus on patient safety, product quality, and data integrity along the lifecycle. Rely on built-in documentation and best practices to achieve compliance with the Good Automated Manufacturing Practice® 5.
codebeamer X’s Pharma GAMP® 5 Template supports pharma companies, suppliers of production devices (automation technology and control systems), and system integrators in applying best practices in the management of computerized systems in a pharma environment.
Ensure high product quality, minimum waste, and compliance with regulations. Achieve optimal visibility on processes, traceability, and process control across the entire lifecycle. Apply science-based risk management, and report on traceability across the entire pharma project lifecycle.
codebeamer X’s Pharma GAMP® 5 Template contains:
- Work items related to specifications, change requests, and bugs that cover the lifecycle
- Hazard analysis functionality and risk-related artifacts that support the reduction/mitigation of hazards
- Work items and processes to help you manage testing activities and releases.