Solution Templates

Computer System Validation (CSV)

Pharmaceutical project validation and quality risk management

Solution Template Computer System Validation - Dashboard Overview
GAMP® 5 or “Good Automated Manufacturing Practice” is a non-mandatory guideline for pharmaceutical and food companies. The guide aims to deliver a cost-effective framework of good practice to ensure that computerized 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 fundamental, most used features of GAMP® 5 to simplify the application of the guidelines, the appropriate operational controls, and the relevant documentation. Through risk minimization early in the process and through process standardization, 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.


Validation-Ready Structure

Including traceability matrix functions and meta data

Risk Assessment

Accompanying system and business risk analysis and assessment

RACI Matrix

Defining roles, responsibilities, and deliverables


The cplace CSV Solution Template efficiently supports the process and documentation of software validation through key process deliverables. From the validation plan to the requirements catalog, from an accompanying risk assessment to the final validation report, the Solution Template supports users according to their roles and responsibilities at every step of the process. This includes the validation of relevant business objects (e.g. epics or user stories), test cases and test runs, as well as reviews and approval mechanisms.

In collaboration with

Solution Profile


  • Type: Solution Template
  • Category: Compliance Management
  • Languages: DE, EN
  • License: Professional
  • Developer: Objectivity & collaboration Factory AG
  • Compatibility: cplace 5.20+

What’s inside

  • Premium Applications: –
  • Standard Applications: Forms Wizard, Meeting App, Tree Table App
  • Platform Capabilities: Low-Code Automation, Change Listeners, Roles and Rights Management

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