Why You Need Computer System Validation
Companies strive to create goals, processes, culture, management, and incentives that build infrastructure. Computer Systems (software) are a dominant and increasing part of business infrastructure. Computer System Validation is process validation and has the following benefits:
- Excellent Return On Investment (ROI) - Cost of compliance is low with respect to potential loss of intellectual property or other potential losses.
- Provides documentation required by FDA, other regulatory agencies, and your customers.
- Maximizes the value of the computer system and the employees that use it.
- Reduces labor costs by increasing employee efficiency and effectiveness.
- Enhances project management to ensure projects are implemented on schedule and on budget.
- Saves money by discovering defects early, before failures occur in production.
- Reduces risk. Legal liability, not regulatory, is often the most important reason to perform validation. Software is made and used by people so it is guaranteed to be imperfect. Software and process defects increase with software complexity. Having the evidence that computer systems are correct for their purpose and operating properly represents a good business practice.
- Promotes continual process improvement. Software is constantly evolving to keep up with the increasingly complex needs of the people that use it. Therefore, validation is an ongoing necessity.