Preconfigured support for the management and validation of GxP compliant computerized and software-based systems for GAMP® 5 compliance.
Use GAMP® 5 Template to manage your pharmaceutical projects and validate manufacturing systems according to established Good Automated Manufacturing Practices. Adhere to GAMP guidelines to maintain focus on patient safety, product quality, and data integrity across the pharma product innovation lifecycle. Reduce waste and optimize the time and effort costs of achieving GAMP® 5 compliance.
This template contains:
- Artifacts to manage specifications, change requests, and bugs in the pharmaceutical project lifecycle
- Work items that support the analysis and management (reduction and/or mitigation) of hazards and risks risks
- Processes for pharma testing and release management activities
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