Written by: Justin Jay, Director of Mid-Atlantic Operations
Computerized systems are critical to reducing the cost and complexity to develop, produce, and maintain cGxP compliance for your products. The architecture and design of your computerized systems leads to maximum efficiency and lower costs to operate and validate your systems.
Validating a computerized system can be a very costly, particularly if you have bought the wrong system or have designed your systems in a way that makes validation tedious or difficult. You need to involve specialist and the end users in the design of your systems. The more complicated a system is the longer it takes for training as well as validation. Technology also is evolving. Additional validation activities may be necessary after software updates and new feature additions. Your computerized systems can turn into liabilities if they are difficult to maintain in a validated state.
You can reduce the time spent in computerized system validation. Focus on the user requirements early in the process. Select the best tool for your work. If possible, select software products like ACE Essentials™, that are fully validated and ready to use, or ACE™, the fully configurable electronic Quality Management System that can adapt to any business process. If you need computerized system validation (CSV) services, select a provider like PSC Biotech who has the experience and capability to validate your software systems on time and on budget.