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

Product and Process Verification and Validation Templates

1. Product Description

Our templates will allow you to be in compliance with ISO 13485, QSR 820, Design Controls and GMP regulations. There are many advantages which will reduce your overall development and validation cost and subsequent failure rates.

  1. It is much faster
  2. A lot cheaper
  3. Much easier
  4. Same look and feel
  5. Product and process of higher quality
  6. Templates will allow you to focus on your product development and testing
  7. Tried and tested templates means you are in compliance with regulations

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 > 40 % > 60 % > 80 %
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