Clinical Research Solutions
Improving Computerized System Quality Through Design Verification
Unverified Design – An Example For those of us who travel routinely, one of the most sought-after treasures in the typical airport terminal is an electrical outlet. With our dependency on mobile...
Clinical Research Solutions
Computer System Validation: Resolutions for the New Year
How are you doing with those New Years’ resolutions? Whether or not you’re a resolution maker (or breaker), you can use this time of year to take stock of where things stand, including your validated...
Clinical Research Solutions
Lean CSV – How to Reduce Waste and Increase Value
What is lean? Lean is a business system focused on continuously improving processes by reducing the time taken and the waste involved in delivering increasing value to the customer. Customers in this...
Clinical Research Solutions
Risk-Based Computer System Validation and Rational Testing
Introduction Risk based approaches to validation of computerized systems have been heavily promoted since the publication of GAMP 5 and ASTM E2500. Yet we continue to see examples of validation...
Clinical Research Solutions
Life Cycle Considerations for High Quality and Regulatory Compliant Software
By way of introduction I have developed, implemented, and validated computer/information systems for longer than I care to admit … they were still using punch cards to program room-sized computers...