Challenges with Paper-Based Computer System Validation (CSV)

16 Risks of Paper-Based Computer Validation

In the life sciences industry, computer validation is typically a manual, paper-based process plagued with inefficiencies, high cost and risk. The inefficiencies stem from manual activities like printing and scanning computer validation documents. The real threat and challenge to companies using paper-based computer validation are the compliance and business risks illustrated below:

Compliance risks related to paper-based validation include the following:

1. Failure to follow approved procedures
2. Difficult to enforce approved validation procedures and validation master plans
3. Lack of consistency
4. Only a single person can access a document at any given time
5. No collaboration is possible when resources work remotely
6. Duplicating a document is not possible if it’s not accessible
7. Difficult to standardize and harmonize the validation process across sites
8. Documentation issues
9. Lost and misplaced records
10. Regulatory observations are more complex to achieve
11. Disaster recovery is almost impossible with paper documents

The inefficiencies that plague paper-based computer validation processes also create business risks, which include the following:

1. Revenue loss
2. Higher operational cost
3. Higher expenses (document storage, archiving, retrieval, resources)
4. Inability to release manufacturing equipment
5. Delayed production schedules

The day-to-day inefficiencies and high cost associated with paper-based computer system validation is mostly based on the need to perform the following activities:

• Creating
• Printing
• Executing and scanning validation documents
• Inefficient cycle times
• Archiving
• Resources for Document Control

Paper-based computer validation is a tedious, time-consuming process that requires a significant amount of resource commitment from the validation and document management teams. Paper-based validation creates delays in releasing critical manufacturing equipment for manufacturing operations, and record retention can be very costly and unsustainable during the lifecycle.

Digitized validation provides an ideal solution to eliminate the risks and inefficiencies that plague paper-based computer validation processes. These systems eliminate paper-based computer validation protocols and enable secure, compliant electronic executions, significantly reducing compliance and business and operational risks while reducing validation cycle time.