Validating Computer Systems in a Regulated Environment: Are You At Risk? Pt 1
Автор: vkbailey1
Загружено: 2011-02-22
Просмотров: 3193
Life sciences companies that develop and bring to market pharmaceuticals, biotechnology, and medical devices face unique needs due to the nature of your business.
• What are your responsibilities?
• How can you expect your software management solutions to assist in the
validation documentation process?
• When should you bring in a third party validation expert?
Join us as we look into FDA requirements for risk based validation during a live, interactive discussion where we'll:
• Explore governance structures used to manage compliance;
• Define the role that software management solutions play in regard to systems
validation and compliance to meet FDA requirements for traceability, tracking,
and electronic signatures;
• Gain insight on who should play what role while going through the validation
process.
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