Implementation of 21 CFR part 11 compliant Regulatory Information Portal for a pharmaceutical organization

About the client: 
The client is one of the fastest extending pharmaceutical companies engaged in developing, manufacturing, and marketing a broad range of pharmaceutical products globally. 

Business Problem:

  • Manual gathering and collation of data from various sections within the regulatory department
  • Lack of single platform to manage regulatory data
  • Increased waiting time in receiving answers to regulatory queries


Solution:

  • Develop and implement single platform to manage regulatory information.
  • Implement 21 CFR Part 11 compliance.
  • Implement intuitive exploration of published regulatory records allowing expedited response to regulatory queries.


Tools and Technologies: 
ASP.NET, Knockout, SharePoint (SQL Server), jqplot, itextsharp(dll), Microsoft openxml SDK