Pharmaceutical project validation and quality risk management
GAMP® 5 or “Good Automated Manufacturing Practice” is a non-mandatory guideline for pharmaceutical and food companies. The guideline aims to provide cost-effective framework of good practice to ensure that computerised systems are effective and of high quality, fit for intended use, and compliant with applicable regulations.
The cplace Solution Template Computer System Validation combines the basic, most commonly used features of GAMP® 5 to simplify the application of the guidelines, the appropriate operational controls, and the relevant documentation. By mitigating risk early in the process and standardizing processes, organizations can reduce costs associated with rework, downtime, and product recalls. This helps ensure patient safety, product quality and data integrity. The Solution Template is suitable for both agile and traditional waterfall approaches to project management.
The cplace Solution Template CSV efficiently supports the process and documentation of software validation through key process deliverables.
Every Step of the Process
From the validation plan to the requirements catalog, from the accompanying risk assessment to the final validation report, the Solution Template supports users at every step of the process according to their roles and responsibilities.
This includes validation of relevant business objects (e.g. epics or user stories), test cases and test runs, as well as reviews and approval mechanisms.
The validation plan schedules all necessary steps on a timeline.
The Solution Template supports the assessment of system and business risks.
CSV helps users plan risk assessment meetings.
The RACI Matrix gives insights into roles, deliverables, and responsibilities.
Validation Ready Structure
Include traceability matrix capabilities and metadata
Accompanying system and business risk analysis and assessment
Define roles, responsibilities, and deliverables
- Type: Solution Template
- Category: Compliance Management
- Languages: DE, EN
- License: Professional
- Developer: Objectivity GmbH
- Compatibility: cplace 5.20+
- Premium Applications: –
- Standard Applications: Forms Wizard, Meeting App, Tree Table App
- Platform Capabilities: Low-Code Automation, Change Listeners, Roles and Rights Management