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

Quality System Manual, Corporate Procedures and Forms Templates

1. Product Description

We have Quality System Manual, Corporate Procedures, Forms template that provides the standard procedures for managing and delivering information technology systems solutions.  Our customized quality policy, manual, procedures and templates will provide you with many advantages like:

  1. A standard approach for managing and delivering systems solutions that is
    consistent with QSR/ISO 13485/GMP/GCP/GLC/ ISO 9000-3 regulations and other applicable standards
  2. A "roadmap" that can serve as:
    • An introduction for new employees to standard practices
    • A checklist for more experienced professionals
    • Identify the company’s target market and quality policy
  3. A single source for standard procedures that will permit the delivery organization to:
    • Eliminate the waste caused by the use of multiple tools and techniques
    • Eliminate the uncertainty associated with a lack of clear procedures
    • Produce consistently high quality deliverables
    • Achieve productivity improvements
    • Deliver solutions in a more efficient (time-compressed) manner
    • Meet and exceed customer's expectations.
  4. A documented baseline for:
    • Quality certification
    • Auditable validation of compliance to standard practice,
    • A program of continuous improvement to methodology, procedures and practices

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 > 20 % > 40 % > 60 %
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