Article on automating validation

Published November 1999 in “Pharmaceutical Tecnology” was the the article “Using New Techniques for Reducing System Validation Time and Cost”. This article described an approach used in an Eli Lilly drug plant for validation of PLCs and an Intellution system where many similar but slightly different programs and pieces of manufacturing equipment were used.

Its an interesting and useful article because it proposes use of automation and white box techniques in the design and qualification of production equipment rather than a strict brute force black box approach.

SoftwareCPR can not provide a copy of the article as it is copyrighted. To obtain a reprint of this and other software validation articles from this publication and its related publications click the link provided and enter part of the title in the search field.

Automating validation article

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.