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March 5, 2015
The diagram below depicts an example CSV lifecycle alignment with ASTM E2500 and GAMP. Building onto a previous post, Lean CSV - How to Reduce Waste and Increase Value, today's blog focuses on...
March 21, 2014
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...
February 20, 2014
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...
July 31, 2013
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...
July 24, 2013
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...
July 3, 2013
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...