Computer System Validation: Step-by-Step Learn computer system validation essentials and eight fundamental steps of implementation for cost saving.Get complementary SOPs and checklists for easy implementation.Five 2-day In-person Interactive GMP, Part11 and Validation seminars available in America, Europe and Asia delivered by Dr. New Version 5 just released Now with Qualification of Virtual Networks With three audio seminars With 26 SOPs Online Audio Seminars come with 10 Best Practice guides for easy implementation New OECD Guide: Using Computer Systems in GLP Studies Understanding and Implementing the new OECD Guide for Computer Systems November 6, 2014 Computer System Validation: Step-by-Step With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation September 2, 2014 Learning from Recent Warning Letters Related to Computer Validation and Part 11 With Clear Recommendations for Corrective and Preventive Actions Cost Effective Computer System Validation: Step-by-Step With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation December 1, 2011 With compliance master plan, checklists, examples, audio seminar and 30 SOPs for easy implementation Click here for more info The CSV Package includes 36 SOPs. Computers are widely used during development and manufacturing of drugs and medical devices.Proper functioning and performance of software and computer systems play a major role in obtaining consistency, reliability and accuracy of data.Computerized system validation (CSV) is the documented process of assuring that a computerized system does exactly what it is designed to do in a consistent and reproducible manner.The validation process begins with the system proposal/requirements definition and continues until system retirement and retention of the e-records based on regulatory rules Documented system requirements are required for CSV as they clearly stipulate the intended use of a computer system application.Understand the structure of validation plan, documentation of ongoing performance, and structure of validation report.
It is also requested by FDA regulations and guidelines through the overall requirement that "equipment must be suitable for it's intended use".
It deals with development and validation of software used in medical devices.
More recently the FDA has released a draft guidance ob using computers in clinical studies (3).
For a fuller understanding of FDA and ISO requirements, as well as an exploration of methods to meet them (with emphasis on currently used applications) please Read More Process validation is a term used in the medical device industry to indicate that a process has been subject to such scrutiny that the result of the process (a product, a service or other outcome) can be practically guaranteed.
This is vitally important if the predetermined requirements of the product can only be assured by destructive testing.