Helping a Client Meet 21CFR11 Regulations and Guidelines

The client is a global medical device, pharmaceutical and biotech company. They were facing increased litigation due to regulatory submissions that did not adhere with FDA 21CFR11 regulations and guidelines. They clearly needed help ensuring that their applications were compliant in GxP regulated areas, so they turned to Syntel based on our life sciences expertise as well as our robust, risk-based computer system validation (CSV) methodology.

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