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

Internal, External and Due Diligence Audits on Acquisition Companies

1. Service Description

We conduct internal department, product, supplier and software audits. We perform gap assessment and prepare you for an external regulatory audit from both domestic and international auditors like FDA, Notified Body, ISO Registrar etc.

There will be productivity increase and cost savings of more than 80% using our service. Your company will save money from several thousand to millions of dollars adding to your bottom line profit.

This service provides planned independent and documented assessment that can be used to determine whether:

  • Quality Management System is in place and sound and effective
  • Agreed-upon requirements are being met
  • Procedures are being followed
  • Procedures are as effective as they could be
  • Claims made as part of a business acquisition are true
  • Product development was done according to procedures, regulations and standards

The types of audit services offered are:

  1. Compliance Audits
    A compliance audit is designed to determine whether or not specific activities have been performed according to documented procedures (SOPs). In a compliance audit, the "rules" (SOPs) are not questioned. The objective is to determine compliance with the rules and the outcome is usually binary; either passed or failed.
  2. Quality and Process Audits
    A Quality Audit focuses on identifying the underlying cause of quality problems. A Process Audit focuses on determining if the current process (written or not) is as effective or not. Process Audits can be very effective in identifying manufacturing development and/or testing practices that may not be as effective as they could be.
  3. Product Audits A Product Audit
    focuses on compliance assessment to design controls aspect of the product development and validation activities.  We provide extensive service on auditing the medical device and software design, development and testing activities. We identify the gaps and recommended actions between your product design activities and design control requirements before marketing application submission to regulatory agencies like FDA and EU.
  4. Due Diligence Audits
    Due Diligence is the intense examination of a target business of any type for a merger or acquisition by a prospective buyer and it can be described as fact-finding to assist in determining whether to buy the business at all, how much to pay for the business and how to structure the acquisition. The principal purpose of Due Diligence is to verify assertions made by the Seller and to identify caveats that may not have been disclosed to the Buyer. More specifically, a due diligence audit is performed to help a buyer understand details of the development process, degree of regulatory compliance, etc. of a target company. he Audit Report prepared as a result of a Due Diligence Audit is extremely critical as it often impacts the business decision of the acquiring company.

2. Cost Savings - Return on Investments (ROI)

Amount of money saved by your company on using our service 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 % > 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 service. Company size is based on annual sales as per FDA classification.


3. Solution Approach

Our audit service approach consists of providing you with

  1. Audit Overview
  2. Audit Preparation
  3. Audit Team(s)
  4. Audit Agenda
  5. Audit Plan and Audit Day Logistics
  6. Audit Report
  7. Conclusion
  8. Executive Summary

The approach can also be customized based on FDA Guide to Quality System Inspection Technique (QSIT) as in Figure 1 focusing on

  1. Quality System
  2. Facilities and Equipment System
  3. Materials System
  4. Production System
  5. Packaging and Labeling System
  6. Laboratory Control System

Managing an Audit Program - Process Flow

Figure 1 - Managing an Audit Program - Process Flow

 

Collecting Information to Reach Audit Conclusions

Figure 2 - Collecting Information to Reach Audit Conclusions

 

Quality System's Sub-systems

Figure 3 - Quality System's Sub-systems - Source FDA QIST Manual


4. Definitions

Audit: An audit is a documented independent inspection and review of a system, which is performed on a periodic basis in accordance with written procedures.  


5. Applicable Laws, Regulations and Standards

  1. ISO 10011-1 1990 - Guidelines for Planning and Performing Quality Audits
  2. ISO 10011-2 1991 - Guidelines for Selecting Quality Auditors
  3. ISO 10011-3 1991 - Guidelines for Managing Quality Audit Programs
  4. Guide to Inspections of Quality Systems - http://www.fda.gov/ora/Inspect_ref/igs/qsit/qsitguide.htm