What is computer system paperless validation (CSV) for Pharma, Medical Devices and Biotech companies?

What is computer system paperless validation (CSV) for Pharma, Medical Devices and Biotech companies?

 

Computer System Validation (CSV)/Paperless Validation is the process of ensuring that any technology component (software or hardware) is fulfilling its purpose to ensure compliance with GMP guidelines and to help organizations maintain consistent quality. The validation is an important assessment and necessity in Life Science. Avoid reinventing the wheel and ensure optimization and efficiency in the validation process

Paperless validation software completely takes away the pitfalls in the usage of a paper-based validation process where more effort & cost involved in doing the activities related to printing, distribution, and storage.

 

What are the benefits of paperless validation software solutions?

  • Paperless validation software solutions provides:
    • Data integrity, consistency, accuracy and control across the organization;
    • Aligned requirements, design and test documents;
    • Electronically review and approval of documents including signatures;
    • Real time validation status, real time metrics, and extensive reporting;
    • User accessibility anytime, anywhere across multiple devices (web, smartphone, tablet);

 

  • Paperless validation software improves:
    • Productivity and reduce time-to-market, changeover and cycle-times;
    • Global collaboration and communication;
  • Paperless validation software facilitates:
    • Teamwork and ensures the progress of activities and be audit ready, anytime;
    • Online execution of testing and deviations;
    • Automated management of change management, document tracking and periodic review;
    • Streamlined review / approval process;

 

  • Paperless validation software reduces:
    • Cycle time for validation activities and saving costs;
    • Costs of purchasing paper itself, costs related to shipping via authorized couries, security of the storage of paper records;
  • Paperless validation software enables:
    • The visibility of validation tasks and provides management up-to-date information to monitor and control to improve the processes;
    • Reuse of content.

What are important business benefits for management when using a paperless validation software approach?

  • The retention of knowledge and easy access to data from the project phase, leveraging of work done across projects
  • Built in quality and compliance in the business process and overall reduction in business risk – quality, safety and operational.

 

Key considerations when selecting a paperless validation software solution:

The key considerations when selecting a paperless validation software solution that works for all systems is the scope or intended use, the process, and the cost. Costs can add up when dealing with software licensing, support, training, and maintenance. Most importantly, it is importance to understand the process prior to selecting a solution. Then, it is useful to think global even if an organization plans to implement locally and to plan for change.

Conclusion:

Paperless validation for Life Science companies is fast becoming essential for survivability, strategic advantage, and overall compliance.

 

Rescop paperless validation software solutions

Our all-in-one Validation Lifecycle Management System (VLMS) software comes equipped with a suite of specially designed solutions, each developed and customized to serve the particular requirements of any computer system validation(CSV) lifecycle process.

Rescop computer system validation enables our customers to implement paperless validations and fulfill FDA CFR 21 Part 11 compliance.