1. 21 CFR Part 11
Product Development Automation
COMPANY A multinational Consumer Products company
BACKGROUND The corporation was operating numerous manufacturing,
distribution, and sales operations throughout the world.
BUSINESS ISSUE Automation of the Product Development process
THE OBJECTIVE Increase speed to market for new products by automating the
Product Development Process while enhancing the use of the existing SharePoint
investments to make the company 21 CFR Part 11 compliant.
THE SOLUTION Documented the Product development process including
creation of process maps and functional requirements of the system.
Architected the appropriate data structures to enable configuration of this solution in
the current SharePoint environment.
Configured the solution to be 21 CFR Part 11 compliant in a SharePoint
environment to support the product development process
Created corresponding test protocols to enable system validation.
Directed execution of test protocols to document the system’s functions meet the
established requirements and summarize the validation in a report that establishes
it fitness for use.
An integrated regulatory goal of this project was to establish the essential 21 CFR
Part 11 compliance documents at the consumer products company. This enabled
future cost savings through automation of subsequent quality and regulatory
processes onto the new regulatory compliant SharePoint environment.
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