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 Change Order Management System (ECOMS)

1. Product Description

Our off-the-shelf automatic change order management system in Microsoft SharePoint 2007 system will be utilized to manage documents stored in controlled library system.  SharePoint supports regulated document management needs by providing a broad set of document management capabilities to store, organize and locate documents, ensure consistency of documents, manage metadata for documents and protect documents from unauthorized access or use.

Following are the Business Requirements drivers for implementing an electronic workflow and e-signature solution at any organization:

  1. Identify all Workflow activities and workflow forms relevant to the core activities of approval, rejection and feedback mechanisms for the CO process
  2. Provide document preparation and/or updating and data gathering activities before a CO process is initiated.
  3. Maintain regulatory compliance of Documents being acted upon through the Change Order Process.
  4. Perform automatic publishing of approved documents to next major version.
  5. Perform Change Order number generation and assignment to each Change Order.

Benefits of Automated Change Order System

  1. Facilitate Document Control to process greater numbers of Change Orders through use of electronic workflow and e-signature.  Automated processes will scale more cost effectively to meet our growing global requirements.
  2. Electronic Routing and e-signature will greatly reduce the need to print, distribute, and manually sign Change Orders.  This will reduce shipping/mailing costs and reduce the time to market.
  3. Reduce errors in the Change Order Process through use of automated processes verses manual processes.  This will reduce the number of reviews and revisions due to a more collaborative document management and approval environment.

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