QualTrax Inc.

Dec. 10, 2004
Document Management Software Aids in FDA Compliance
Companies looking for a cost-effective solution to comply with FDA Section 21 CFR Part 11 find QualTrax Rx to be a feature-rich toolset that can grow with their business, according to the supplier.Not only are the benefits of an electronic document and content management solution apparent for pharmaceutical, medical device and biologic companies, but the risks of not having this type of solution are significant. According to PhRMA (Pharmaceutical and Research Manufacturers Association), "The opportunity cost of a new blockbuster drug missing its launch date due to FDA compliance violation is $1 million per day."In addition to the existing document and process management functionality that comes standard with QualTrax, QualTrax Rx features electronic signature authentication, PDF rendering for tamper proof documents, different levels of document security and a revision comparison tool. QualTrax Rx also offers Validation Protocol Workbooks, Site Acceptance Procedures and training services to assist clients with software implementation and ensure compliance with the FDA. The QualTrax software solution is easily customized to fit company processes and integrate with external applications.