Antrix, Inc ANTRIX, Inc
Regulatory Affairs & Quality Assurance Consulting Services for
Medical Device and Medicinal Drugs
O 408 733 1199
F 408 730 5959

Electronic Document Management System (EDMS)

1. Product Description

An electronic document management system (EDMS) is a computer system (or set of computer programs) used to track and store electronic documents, photos, and scanned images of paper documents. It is often viewed as a component of an organization’s Enterprise Content Management Systems.

Our customized off the shelf solution for electronic document management system allows drug and device companies to store a variety of information (regulatory documents, clinical trial results, study reports, communication with regulatory agencies, marketing applications, annual reports, etc.) in an organized manner.

We provide and customize to your need

  1. Plug-ins and Toolkits

  2. File System and Servers

  3. Electronic Document Management System

  4. Electronic Submission Publishing System

  5. ISO/QSR/cGMP Validation of the Systems

2. Cost Savings - Return on Investments (ROI)

Amount of money saved by your company on using our customized product based on the company size is provided in the Table 1.0.

Projected savings is based on

  1. Process efficiency gains (people)
  2. Less personnel requirements (people)
  3. Infrastructure efficiency gains (systems)
  4. Infrastructure validation and maintenance (systems)
  5. Delivering quality products
  6. Avoid regulatory noncompliance cost
  7. Avoid regulatory fines cost

Compared to cost associated with company's inefficient internal manual methods, , systems, tools, software’s, and personnel etc. Detailed Return on Investment (ROI) information is available on request.

Company Size Small Medium Large
$Savings > 90 % > 90 % > 90 %
Annual Sales < $100 million $100 million < Sales < $500 million > $500 million
Number of Submissions <= 2 per year 2 < Sub <= 4 per year > 4 per year

Table 1.0 - Amount of money saved by your company on using our product. Company size is based on annual sales as per FDA classification.

3. Price

$ or call