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

Electronic Nonconformance Report (NCMR), Deviation, CAPA, Supplier, Audit & Training Management System

1. Product Description

We can deploy NCMR, Deviation, CAPA, Supplier, Audit and Training Management systems

Benefits of Automated NCMR, Deviation, CAPA, Supplier, Audit and Training Management System

  1. Expedited paper less electronic initiation, processing, approval and closure of the NCMR, Deviation, CAPA, Supplier, Audit and Training systems

  2. Supports distributed review and approval across sites

  3. Secure easier access to the content with good searching, viewing, reporting and printing capability

  4. Eliminates cost of handling, routing, tracking and managing paper records

  5.  Reduce cost associated with maintenance of records


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

$ sales@antrix.com or call