What is eCSV?

 

eCSV – Complete Paperless Computer System Validation (CSV) Process

DoQStack® eCSV is designed to manage the entire CSV lifecycle electronically and remove the inefficiencies of the paper-based system. Transitioning from manual to an electronic medium; uses computer system validation tools to automate assurance activities.
  • With 100% paperless CSV activity will lead to better cost efficiency by optimizing and stabilizing existing processes
  • Helps bring in the power of Industry 4.0
  • Helps achieve current policies to align with the CSA approach
  • It Helps bridge the gaps in current validation practices
  • Going ahead with an electronic approach will improve overall performance and bring transparency in the entire approach
  • Will lead to a streamlined validation process, critical thinking, product quality, data integrity, operational efficiency, and effectiveness
Image of human hands during discussion of business document in touchscreen at meeting
What is the Key Aspect of eCSV
 

eCSV Template

GAMP 5 category document structure will be available, select the require document to add in the project.

Workflow

According to the project the Project coordinator can assign users and can define each document timelines.

eSignature

Each document will be authorised by the document users with digital stamping.

Notification

Auto user reminder for pending activity by email dashboard alerts.

Automated Traceability Matrix

Generates automated TM against FS and URS documents

Project Tracking Reports

Project status or task status can be monitor by the project coordinators.

Test scripting execution with smart capture

Auto Executions of Test scripts and generate the summary report.

Smart Capture –Evidence Capturing tool

 

How does smart test scripting tool work ?

Smart capture is an automation tool, design to run test scripts.

For every Process it is difficult to understand the logic of work, the quality of product and the best practice.

And in pharmaceuticals and life sciences industry this process is acquired in CSV practices. Where the 100% use of resource is applicable and the best practice of process to be followed for 100% results.

To record these results and map it with the user expectation we have Automated the process of validation with so the expected outputs to be achieved.

Benefits of Paperless CSV
  • Full traceability of project progress
  • Holistic view of validation life cycle
  • Minimized risk by enforcement of consistency
  • Reduced departmental conflicts with real-time status
  • Standardized processes using workflows and document templates
  • Have real-time collaboration with distributed teams
  • Reduced human errors, and time hindering
  • Thereby removes non-compliance risk, maintaining thorough data integrity over auto testing and documenting
Image of human hands during discussion of business document in touchscreen at meeting