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Want to bring FDA inspection in-house?

With ieQip, you can conduct audit the FDA way plus with AI empowerment!

How ieQip came about?

I, Binh Nguyen, had worked for FDA for over 20 years and had conducted many FDA inspections.  I also worked in the hospital for over 20 years and continue to see drug shortages.  I thought it would be BENEFICIAL to create a compliance software that aides industry not on stay in compliance but produce high quality products (FDA regulated products) for patients.  Therefore, I decided to build this software.

What is ieQip?

1.  ieQip stands for intelligent electronic Quality inspection platform

2.  This is a 100% electronic software with AI (artificial intelligence)

3.  ieQip can generate mock FDA-483 and EIR (Establishment Inspection Report)

4.  AI empowers auditors to find quicker answers

5.  ieQip can be licensed inhouse to companies so that they can hire auditors and/or use internal auditors to conduct audits and keep all information internally.  In other words, if you hire consultants to conduct audits whether it's your companies or third party contractors, you can control the audit where information is entirely controlled by licensees.

6.  You can see audit results in real time as each auditor conducts the work

7.  ieQip can provide rating so you can focus on the problems (see this posting https://www.linkedin.com/posts/binh-nguyen-a77046190_providing-quality-solutions-to-biopharmaceutical-activity-7255388945406939137-6tkt?utm_source=share&utm_medium=member_desktop for more information)

8.  Wynngate can provide FDA audit training allowing companies to understand FDA way of conducting inspections

What else will ieQip deliver?

1.  The first focus of this software is on pharmaceuticals inspection including combination products

2.  AI will be made available for all FDA regulated commodities

3.  ieQip will expand to other global regulatory bodies

4.  AI will also expand globally so we can compare similarities and differences among global regulators to assist companies penetrate their products globally

5.  ieQip will attempt to harmonize regulations around the world making it easier to make products available in multiple markets

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