Validating corporate computer systems
The more complex the software becomes, the more likely the existence of errors becomes.It is good business sense to prove to customers that the existing computer systems do what they are intended to do both functionally and operationally. Computer system validation is required by FDA regulations and international quality standards, including: 21 CFR Part 11, 21 CFR Part 820, ICH Q9, ISO 13416, and European Union’s Annex 11.
Hundreds of companies around the world use Master Control to automate core business processes and document management activities to promote collaboration, improve decision making, and accelerate time to market.
This white paper, published by Master Control, offers practical strategies for reducing overall validation time and costs.
It explains the benefits of implementing a risk-based approach to computer systems validation.
risk, as it applies to the use of ER/ES capability Understand how to effectively document the process of computer system validation where ER/ES capability exists, and maintain current information about the various systems in your organization and how they are maintained in a validated state Learn how to gain information about trends in ER/ES validation, as industry progresses and new best practices emerge Understand some of the key “pitfalls” to avoid when employing ER/ES capability Interactive Q&A Session Who Will Benefit: This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco.
Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.