Get your ticket now: cplace Day on October 10, 2024 - Europe's biggest PPM Conference Register for free
Solution Templates

Computer System Validation

Pharmaceutical project validation and quality risk management

Request demo
CSV - Header

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.

Icon Multiple Stars

Efficient Support

The cplace Solution Template CSV efficiently supports the process and documentation of software validation through key process deliverables and structured data collection. 

Icon Clock Setting 71

Every Step of the Process

From the validation plan to the requirements catalog, from the risk assessment to the validation report, the Solution Template supports users at every step of the process.

Icon Check 89

Validation

This includes the validation of business objects (e.g. epics or user stories), test cases and test runs as well as reviews and release mechanisms that are integrated into the validation process.

This Solution Template was developed by

Product Highlights

Structured Approach

The validation plan schedules all necessary steps on a timeline.

CSV - Structured Approach

Risk Assessment

The Solution Template supports the assessment of system and business risks.

CSV - Risk Assessment

Meeting Management

CSV helps users plan risk assessment meetings.

CSV - Meeting Management

Clear Responsibilities

The RACI Matrix gives insights into roles, deliverables, and responsibilities.

CSV - Clear Responsibilities

Benefits

Icon Check 89

 Validation Ready Structure

Include traceability matrix capabilities and metadata

Icon Shield Check

Risk Assessment

Accompanying system and business risk analysis and assessment

Icon User Multiple Group

 RACI Matrix

Define roles, responsibilities, and deliverables

Overview

Facts

  • Category: Project Management 
  • Developer: Accenture GmbH
  • Compatibility: cplace 23.2+

 

This Solution Template uses the cplace functionalities Low-Code Automations, Roles & Permissions. 

Required Licenses

The free use of this Solution Template is based on the licensing of the following products:

  • cplace Platform: Professional or higher
  • Premium Application: —

Explore Related Products

Project planning Gantt diagram
toolkit

Collaborative Scheduling

The classic Gantt diagram with innovative extensions: Drill down into any planning element as deeply as necessary.

Read more