10/03/2013 07:37 PM10/04/2013 01:37 AMTraining Topic: Computer System and Software ValidationInstructor: Peter Spath
Even before the Electronic Records and Electronic Signature Regulations were promulgated, regulated industries were required to validate computer systems. These requirements are also found in various ISO Standards to which an organization may wish to register. Over the years more processes, equipment, and office systems have become influenced or controlled by computers.
As required by Regulations;
21CFR Part 820.70(i) Automated processes: When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to and established protocol. All software changes shall be validated before approval and issuance. 21CFR Part 11 Electronic Records; Electronic Signatures: This regulation is a minimum set of criteria for controlling records if you choose to use electronic means to create, modify, maintain, archive, retrieve, or transmit any records required by agency regulations.
Why Should you Attend:
Any organization using computer systems to control manufacturing and test equipment, processes, or manage records must validate the software for its intended use. Software validation can appear to be an intimidating endeavor when an organization considers the number of systems in use.
Objectives of the Presentation:
What is involved in software validation
How to get your validation program started
How should an organization decide which systems require validation
How does an organization assure their systems are compliant